Trial Outcomes & Findings for A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery (NCT NCT03891524)
NCT ID: NCT03891524
Last Updated: 2025-03-30
Results Overview
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1242 participants
Primary outcome timeframe
Up to Day 14
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
150
|
153
|
150
|
149
|
152
|
153
|
301
|
|
Overall Study
Safety Analysis Set
|
33
|
150
|
148
|
148
|
147
|
149
|
148
|
296
|
|
Overall Study
COMPLETED
|
34
|
149
|
151
|
149
|
147
|
150
|
151
|
299
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
1
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
1
|
2
|
2
|
2
|
1
|
Baseline Characteristics
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
Baseline characteristics by cohort
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=34 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=153 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=149 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=152 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=153 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=301 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
Total
n=1242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 5.74 • n=93 Participants
|
67.9 years
STANDARD_DEVIATION 8.03 • n=4 Participants
|
68.4 years
STANDARD_DEVIATION 8.49 • n=27 Participants
|
68.8 years
STANDARD_DEVIATION 8.17 • n=483 Participants
|
68 years
STANDARD_DEVIATION 8.25 • n=36 Participants
|
67 years
STANDARD_DEVIATION 8 • n=10 Participants
|
68.6 years
STANDARD_DEVIATION 7.76 • n=115 Participants
|
67.8 years
STANDARD_DEVIATION 7.97 • n=40 Participants
|
68 years
STANDARD_DEVIATION 8.02 • n=8 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
108 Participants
n=36 Participants
|
102 Participants
n=10 Participants
|
106 Participants
n=115 Participants
|
208 Participants
n=40 Participants
|
876 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
50 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
93 Participants
n=40 Participants
|
366 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
42 Participants
n=40 Participants
|
156 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
125 Participants
n=483 Participants
|
125 Participants
n=36 Participants
|
129 Participants
n=10 Participants
|
133 Participants
n=115 Participants
|
250 Participants
n=40 Participants
|
1037 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
49 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
136 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
124 Participants
n=4 Participants
|
134 Participants
n=27 Participants
|
132 Participants
n=483 Participants
|
129 Participants
n=36 Participants
|
132 Participants
n=10 Participants
|
136 Participants
n=115 Participants
|
260 Participants
n=40 Participants
|
1081 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
Asia
|
0 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
134 Participants
n=8 Participants
|
|
Region of Enrollment
Europe
|
21 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
64 Participants
n=36 Participants
|
64 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
129 Participants
n=40 Participants
|
528 Participants
n=8 Participants
|
|
Region of Enrollment
South America
|
0 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
55 Participants
n=8 Participants
|
|
Region of Enrollment
North America
|
5 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
38 Participants
n=40 Participants
|
160 Participants
n=8 Participants
|
|
Region of Enrollment
Western Europe
|
8 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
46 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
89 Participants
n=40 Participants
|
365 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: The modified Intent-to-treat (mITT) analysis set included all intent-to-treat (ITT) participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic proximal DVT, PE or death as adjudicated by the CEC.
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=252 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
|
7 Participants
|
30 Participants
|
27 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
10 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14; Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Any bleeding was defined as the composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Bleeding Event (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
8 Participants
|
2 Participants
|
7 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
|
Number of Participants With Any Bleeding Event (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
8 Participants
|
2 Participants
|
7 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52. Also included the participants whose venography result was not evaluable distal but no proximal clot.
Total VTE was defined as the composite of (CEC-adjudicated) proximal and/or DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=135 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=253 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Total VTE (CEC-adjudicated)
|
7 Participants
|
30 Participants
|
27 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
10 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14, Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Composite of Major bleeding event (BE): Fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; surgical site bleeding that requires second intervention open, arthroscopic, endovascular,or hemarthrosis resulting in prolonged hospitalization, deep wound infection and/or either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: Epistaxis, Gastrointestinal bleed,Hematuria,Bruising/ecchymosis,Hemoptysis,Hematoma.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14; Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Number of participants with major BE (adjudicated by CEC) were reported. Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Major Bleeding Events (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Major Bleeding Events (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14; Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With CRNM Bleeding Events (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With CRNM Bleeding Events (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14; Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14; Up to Day 52Population: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated)
Up to Day 14
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated)
Up to Day 52
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=135 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=253 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Major VTE (CEC-adjudicated)
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=252 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Major VTE (CEC-adjudicated)
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The mITT analysis set at Day 14 includes all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death). Also includes the subjects whose venography result is not evaluable distal but no proximal clot.
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=29 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=134 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=133 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=136 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=135 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=259 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Asymptomatic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Symptomatic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52 and also included the participants whose venography result was not evaluable distal but no proximal clot.
Number of participants with proximal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=29 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=135 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=133 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=137 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=135 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=260 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Proximal DVT (CEC-adjudicated)
Asymptomatic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Proximal DVT (CEC-adjudicated)
Symptomatic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).
Number of participants with distal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=252 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Distal DVT (CEC-adjudicated)
Asymptomatic
|
7 Participants
|
27 Participants
|
26 Participants
|
13 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
50 Participants
|
|
Number of Participants With Distal DVT (CEC-adjudicated)
Symptomatic
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=135 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=253 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Distal DVT (CEC-adjudicated)
Asymptomatic
|
7 Participants
|
27 Participants
|
26 Participants
|
13 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
50 Participants
|
|
Number of Participants With Distal DVT (CEC-adjudicated)
Symptomatic
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=252 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=135 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=253 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).
Number of participants with deaths (CEC-adjudicated) were reported.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=252 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Deaths (CEC-adjudicated)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.
Number of participants with deaths (CEC-adjudicated) were reported.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=128 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=135 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=253 Participants
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Deaths (CEC-adjudicated)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The pharmacokinetic (PK) analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for overall participants and not group wise.
Apparent clearance of a drug was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=921 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of JNJ-70033093
|
7.72 Liter per hour (L/h)
Geometric Coefficient of Variation 39.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for overall participants and not group wise.
V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=921 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (V/F) of JNJ-70033093
|
125 Liter
Geometric Coefficient of Variation 60.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on sex (male and female) to report the effect of sex on CL/F.
Impact of demographic character (sex) on CL/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=653 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=268 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographics: Apparent Clearance (CL/F) Based on Sex
|
7.14 Liter per hour (L/h)
Geometric Coefficient of Variation 38.5
|
9.32 Liter per hour (L/h)
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on age to report the effect of age on CL/F.
Impact of age on CL/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=464 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=457 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographic: Age on CL/F
|
8.70 L/h
Geometric Coefficient of Variation 36.9
|
6.83 L/h
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on weight to report the effect of weight on CL/F.
Impact of weight on CL/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=486 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=435 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographic: Weight on CL/F
|
7.04 L/h
Geometric Coefficient of Variation 37.9
|
8.54 L/h
Geometric Coefficient of Variation 38.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on CRCL to report the effect of renal function on CL/F.
Impact of renal function on CL/F was assessed. The outcome measure was reported based on CRCL.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=442 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=447 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Laboratory Values: Renal Function on CL/F
|
6.71 L/h
Geometric Coefficient of Variation 38.1
|
8.83 L/h
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on sex (male and female) to report the effect of sex on V/F.
Impact of sex on V/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=653 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=268 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographics: Sex on Apparent Volume of Distribution (V/F)
|
118 Liters
Geometric Coefficient of Variation 61.2
|
143 Liters
Geometric Coefficient of Variation 56.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on age to report the effect of age on V/F.
Impact of age on V/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=464 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=457 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographics : Age on V/F
|
135 Liters
Geometric Coefficient of Variation 59.5
|
116 Liters
Geometric Coefficient of Variation 60.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on weight to report the effect of weight on V/F.
Impact of weight on V/F was assessed.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=486 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=435 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Demographics : Weight on V/F
|
109 Liters
Geometric Coefficient of Variation 58.8
|
145 Liters
Geometric Coefficient of Variation 57.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on CRCL to report the effect of renal function on V/F.
Impact of renal function on V/F was assessed. The outcome measure is reported based on CRCL.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=442 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=447 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Impact of Selected Laboratory Values: Renal Function on V/F
|
116 Liters
Geometric Coefficient of Variation 62.2
|
135 Liters
Geometric Coefficient of Variation 58.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=28 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=127 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=129 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=124 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=123 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=134 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=131 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Trend Test for Primary Efficacy Event Rate (CEC Adjudicated) by Multiple Comparison Procedure - Modelling (MCP-Mod) Approach
|
0.35 proportion of participants
Interval 0.17 to 0.52
|
0.21 proportion of participants
Interval 0.16 to 0.25
|
0.20 proportion of participants
Interval 0.15 to 0.24
|
0.13 proportion of participants
Interval 0.1 to 0.16
|
0.09 proportion of participants
Interval 0.07 to 0.12
|
0.09 proportion of participants
Interval 0.06 to 0.11
|
0.07 proportion of participants
Interval 0.03 to 0.1
|
—
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Outcome measures
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 Participants
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 Participants
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 Participants
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 Participants
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 Participants
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Trend Test for the Composite of On-Treatment Major and Clinically Relevant Nonmajor Bleeding (CEC Adjudicated) by MCP-Mod Approach
|
0.02 proportion of participants
Interval 0.0 to 0.17
|
0.01 proportion of participants
Interval 0.0 to 0.03
|
0.01 proportion of participants
Interval 0.0 to 0.04
|
0.01 proportion of participants
Interval 0.0 to 0.02
|
0.01 proportion of participants
Interval 0.0 to 0.02
|
0.01 proportion of participants
Interval 0.0 to 0.02
|
0.01 proportion of participants
Interval 0.0 to 0.02
|
—
|
Adverse Events
JNJ-70033093 25 mg Once Daily + Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
JNJ-70033093 50 mg Once Daily + Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
JNJ-70033093 50 mg BID
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
JNJ-70033093 200 mg Once Daily + Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
JNJ-70033093 100 mg + Placebo BID
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
JNJ-70033093 200 mg BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Enoxaparin 40 mg Once Daily
Serious events: 11 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 participants at risk
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 participants at risk
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 participants at risk
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 participants at risk
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 participants at risk
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 participants at risk
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 participants at risk
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 participants at risk
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.67%
1/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Injury, poisoning and procedural complications
Periprosthetic Fracture
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Investigations
Cardiovascular Evaluation
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Investigations
Full Blood Count Decreased
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.67%
1/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.67%
1/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.67%
1/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.0%
1/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.67%
1/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
1.3%
2/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Vascular disorders
Femoral Artery Embolism
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.68%
1/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.00%
0/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
0.34%
1/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
Other adverse events
| Measure |
JNJ-70033093 25 mg Once Daily + Placebo
n=33 participants at risk
Participants received JNJ-70033093 25 milligrams (mg) (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg Once Daily + Placebo
n=150 participants at risk
Participants received JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 25 mg + Placebo Twice Daily (BID)
n=148 participants at risk
Participants received JNJ-70033093 25 mg (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
|
JNJ-70033093 50 mg BID
n=148 participants at risk
Participants received JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg Once Daily + Placebo
n=147 participants at risk
Participants received JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
|
JNJ-70033093 100 mg + Placebo BID
n=149 participants at risk
Participants received JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
|
JNJ-70033093 200 mg BID
n=148 participants at risk
Participants received JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days.
|
Enoxaparin 40 mg Once Daily
n=296 participants at risk
Participants received enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
4.0%
6/150 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
6.1%
9/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
5.4%
8/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
2.0%
3/147 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
2.7%
4/149 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
2.0%
3/148 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
5.7%
17/296 • Up to 6 weeks
The safety analysis set is a subset of the intent to treat (ITT) analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.
|
Additional Information
Senior Director Clinical Development
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER