Trial Outcomes & Findings for Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass (NCT NCT02037555)
NCT ID: NCT02037555
Last Updated: 2019-03-15
Results Overview
Major morbidity composite defined as a composite of any one or more of the following: 1. Postoperative mortality (deaths occurring within 30 days of the operation or occurring during the primary hospitalization). 2. Stroke (clinical diagnosis of focal or global neurological deficit of abrupt onset caused by disturbance in cerebral blood supply). 3. Acute kidney injury (increase of serum creatinine levels to \>2.0 mg/dL and twice the baseline level or a new requirement for dialysis postoperatively). 4. Surgical reexploration (return to operating room because of bleeding, tamponade, graft occlusion or other cardiac reason). 5. Arterial or venous thromboembolic event (perioperative myocardial or mesenteric infarction, peripheral thromboembolism, acute coronary graft thrombosis, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism). 6. Prolonged mechanical ventilation (\>24 hours). 7. Infection (deep sternal-wound infection and/or bloodstream infections).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
425 participants
Primary outcome timeframe
Up to Day 30 +/- 4 days
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
AT-III (Human)
Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:
AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4
|
Placebo
Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
212
|
|
Overall Study
Dosed
|
201
|
198
|
|
Overall Study
Dosed and Operated On
|
200
|
196
|
|
Overall Study
COMPLETED
|
190
|
191
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
Baseline characteristics by cohort
| Measure |
AT-III (Human)
n=201 Participants
Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:
AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4
|
Placebo
n=198 Participants
Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 12.80 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Age, Customized
Age Category · <65 years
|
78 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Customized
Age Category · ≥65 years
|
123 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30 +/- 4 daysPopulation: All subjects Treated and Operated On Excluding 4 Subjects with Non-verifiable Data
Major morbidity composite defined as a composite of any one or more of the following: 1. Postoperative mortality (deaths occurring within 30 days of the operation or occurring during the primary hospitalization). 2. Stroke (clinical diagnosis of focal or global neurological deficit of abrupt onset caused by disturbance in cerebral blood supply). 3. Acute kidney injury (increase of serum creatinine levels to \>2.0 mg/dL and twice the baseline level or a new requirement for dialysis postoperatively). 4. Surgical reexploration (return to operating room because of bleeding, tamponade, graft occlusion or other cardiac reason). 5. Arterial or venous thromboembolic event (perioperative myocardial or mesenteric infarction, peripheral thromboembolism, acute coronary graft thrombosis, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism). 6. Prolonged mechanical ventilation (\>24 hours). 7. Infection (deep sternal-wound infection and/or bloodstream infections).
Outcome measures
| Measure |
AT-III (Human)
n=198 Participants
Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:
AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4
|
Placebo
n=194 Participants
Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia
|
|---|---|---|
|
Percentage of Subjects With Any Component of a Major Morbidity Composite
|
68 Participants
|
58 Participants
|
Adverse Events
AT-III (Human)
Serious events: 57 serious events
Other events: 185 other events
Deaths: 7 deaths
Placebo
Serious events: 57 serious events
Other events: 179 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
AT-III (Human)
n=199 participants at risk
Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:
AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4
|
Placebo
n=196 participants at risk
Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
9/199 • Number of events 9 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.5%
3/199 • Number of events 3 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Heparin induced thrombocytopenia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Arrhythmia
|
2.0%
4/199 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Arrhytmia supraventricular
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
5/199 • Number of events 5 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
3.1%
6/196 • Number of events 7 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Atrioventricular block complete
|
2.0%
4/199 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
2.0%
4/196 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Bradycardia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiac failure
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiogenic shock
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
2.0%
4/196 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Pericardial effusion
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Pulseless electrical activity
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
General disorders
Non-cardiac chest pain
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Hepatobiliary disorders
Liver injury
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Cellulitis
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Clostridium difficile infection
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Infection
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Pneumonia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Sepsis
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Septic shock
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Wound infection
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Cardiac vein perforation
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.0%
4/199 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Investigations
Pulmonary arterial pressure increased
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Aphasia
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
2.6%
5/196 • Number of events 5 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Embolic stroke
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Encephalopathy
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Product Issues
Device breakage
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Psychiatric disorders
Delirium
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Psychiatric disorders
Mental status changes
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.5%
3/196 • Number of events 3 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
3/199 • Number of events 3 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
4/199 • Number of events 4 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.5%
3/196 • Number of events 3 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Surgical and medical procedures
Decompressive craniectomy
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Aortic rupture
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
1.0%
2/196 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Extravasation blood
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/199 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.51%
1/196 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Hypotension
|
0.50%
1/199 • Number of events 1 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Peripheral ischaemia
|
1.0%
2/199 • Number of events 2 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
0.00%
0/196 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
Other adverse events
| Measure |
AT-III (Human)
n=199 participants at risk
Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula:
AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4
|
Placebo
n=196 participants at risk
Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Placebo: 0.9% Sodium Chloride for Injection, United States Pharmacopeia
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
48/199 • Number of events 48 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
18.4%
36/196 • Number of events 36 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
6.5%
13/199 • Number of events 13 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
4.1%
8/196 • Number of events 8 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
12.6%
25/199 • Number of events 25 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
16.3%
32/196 • Number of events 32 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
22.1%
44/199 • Number of events 44 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
25.5%
50/196 • Number of events 50 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
57/199 • Number of events 57 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
32.7%
64/196 • Number of events 64 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Arrhythmia
|
5.0%
10/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
4.1%
8/196 • Number of events 8 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Atrial fibrillation
|
28.1%
56/199 • Number of events 61 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
20.4%
40/196 • Number of events 42 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Cardiogenic shock
|
8.0%
16/199 • Number of events 16 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
9.2%
18/196 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Low cardiac output syndrome
|
6.0%
12/199 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.1%
10/196 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Cardiac disorders
Tachycardia
|
5.0%
10/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.1%
14/196 • Number of events 14 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Constipation
|
16.6%
33/199 • Number of events 34 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
20.4%
40/196 • Number of events 40 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Gastrointestinal disorders
Nausea
|
16.6%
33/199 • Number of events 34 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
19.9%
39/196 • Number of events 39 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
General disorders
Oedema
|
3.5%
7/199 • Number of events 7 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
General disorders
Oedema peripheral
|
6.5%
13/199 • Number of events 16 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Infections and infestations
Urinary tract infection
|
5.5%
11/199 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
2.6%
5/196 • Number of events 5 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
9.0%
18/199 • Number of events 18 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
9.7%
19/196 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
3.5%
7/199 • Number of events 8 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
5.5%
11/199 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
4.1%
8/196 • Number of events 8 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
27.1%
54/199 • Number of events 54 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
32.7%
64/196 • Number of events 64 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.5%
11/199 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Investigations
International normalised ratio increased
|
9.5%
19/199 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
9.7%
19/196 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Investigations
Myocardial necrosis marker increased
|
3.0%
6/199 • Number of events 6 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.1%
10/196 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Investigations
Prothrombin time prolonged
|
8.0%
16/199 • Number of events 16 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
9.7%
19/196 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
5.5%
11/199 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.0%
12/199 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.7%
15/196 • Number of events 15 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
5.0%
10/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.1%
14/196 • Number of events 14 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
31.2%
62/199 • Number of events 63 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
31.1%
61/196 • Number of events 61 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.0%
18/199 • Number of events 18 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.0%
14/199 • Number of events 14 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.1%
14/196 • Number of events 14 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
8.5%
17/199 • Number of events 17 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
14.3%
28/196 • Number of events 28 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.5%
19/199 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
14.3%
28/196 • Number of events 28 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
4.5%
9/199 • Number of events 9 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
15/199 • Number of events 15 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.1%
14/196 • Number of events 14 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.5%
11/199 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
6.6%
13/196 • Number of events 13 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
9.5%
19/199 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.1%
14/196 • Number of events 15 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/199 • Number of events 6 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
6.1%
12/196 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Renal and urinary disorders
Acute kidney injury
|
14.6%
29/199 • Number of events 30 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.5%
9/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 11 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
21.6%
43/199 • Number of events 43 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
24.5%
48/196 • Number of events 51 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
10/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
4.1%
8/196 • Number of events 8 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.1%
50/199 • Number of events 51 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
24.5%
48/196 • Number of events 50 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.5%
13/199 • Number of events 13 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
5.6%
11/196 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.0%
10/199 • Number of events 10 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
8.2%
16/196 • Number of events 16 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.1%
26/199 • Number of events 29 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
15.8%
31/196 • Number of events 32 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
3.5%
7/199 • Number of events 7 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
6.1%
12/196 • Number of events 12 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Hypertension
|
7.5%
15/199 • Number of events 15 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
9.7%
19/196 • Number of events 19 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Hypotension
|
25.6%
51/199 • Number of events 52 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
29.6%
58/196 • Number of events 61 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
|
Vascular disorders
Hypovolaemic shock
|
4.5%
9/199 • Number of events 9 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
7.7%
15/196 • Number of events 15 • Up to Day 30 +/- 4 days
Four subjects included in the participant flow table are excluded from safety and efficacy reporting. These 4 subjects, 2 from each treatment group, were subtracted from the 399 "Dosed" subjects planned for safety reporting and the 396 "Dosed and Operated on" subjects planned for efficacy reporting. The final population for safety reporting was 395 (AT-III n=199 \[ie, 201-2\] + Placebo n=196 \[ie, 198-2\]), and for efficacy reporting was 392 (AT-III n=198 \[ie, 200-2\] + Placebo n=194 \[ie, 196-2\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A 12-month post-study period is reserved for a joint, multi-center publication of study results. After this period, individual sites may publish results provided that the Sponsor is allowed 30 days to review any proposed publication for removal of confidential, protected, and trademarked material prior to submission with an option to delay publication up to 60 days if needed to protect its interests. The Sponsor shall retain the option to receive acknowledgment for its sponsorship of the study.
- Publication restrictions are in place
Restriction type: OTHER