Trial Outcomes & Findings for Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old (NCT NCT04122170)
NCT ID: NCT04122170
Last Updated: 2024-04-08
Results Overview
Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
207 participants
Primary outcome timeframe
Baseline (pre-dose) to 4 hours after the start of infusion
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
Bentracimab (PB2452)
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion: Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong cytochrome P450 3A isozyme (CYP3A) inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
|
Placebo
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Placebo (0.9% Sodium chloride) infusion: 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
51
|
|
Overall Study
COMPLETED
|
150
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of subjects with observation at baseline.
Baseline characteristics by cohort
| Measure |
Bentracimab (PB2452)
n=154 Participants
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion: Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
|
Placebo
n=51 Participants
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Placebo (0.9% Sodium chloride) infusion: 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 6.90 • n=154 Participants
|
60.9 years
STANDARD_DEVIATION 6.76 • n=51 Participants
|
61.2 years
STANDARD_DEVIATION 6.85 • n=205 Participants
|
|
Age, Customized
<= 65 years
|
107 Participants
n=154 Participants
|
39 Participants
n=51 Participants
|
146 Participants
n=205 Participants
|
|
Age, Customized
> 65 years
|
47 Participants
n=154 Participants
|
12 Participants
n=51 Participants
|
59 Participants
n=205 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=154 Participants
|
30 Participants
n=51 Participants
|
102 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=154 Participants
|
21 Participants
n=51 Participants
|
103 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=154 Participants
|
7 Participants
n=51 Participants
|
25 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=154 Participants
|
44 Participants
n=51 Participants
|
180 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
3 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=154 Participants
|
8 Participants
n=51 Participants
|
37 Participants
n=205 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=154 Participants
|
43 Participants
n=51 Participants
|
164 Participants
n=205 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=154 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=205 Participants
|
|
Region of Enrollment
Canada
|
23 participants
n=154 Participants
|
8 participants
n=51 Participants
|
31 participants
n=205 Participants
|
|
Region of Enrollment
United States
|
131 participants
n=154 Participants
|
43 participants
n=51 Participants
|
174 participants
n=205 Participants
|
|
Renal Group
Normal
|
46 Participants
n=151 Participants • Number of subjects with observation at baseline.
|
16 Participants
n=50 Participants • Number of subjects with observation at baseline.
|
62 Participants
n=201 Participants • Number of subjects with observation at baseline.
|
|
Renal Group
Mild
|
91 Participants
n=151 Participants • Number of subjects with observation at baseline.
|
30 Participants
n=50 Participants • Number of subjects with observation at baseline.
|
121 Participants
n=201 Participants • Number of subjects with observation at baseline.
|
|
Renal Group
Moderate
|
14 Participants
n=151 Participants • Number of subjects with observation at baseline.
|
4 Participants
n=50 Participants • Number of subjects with observation at baseline.
|
18 Participants
n=201 Participants • Number of subjects with observation at baseline.
|
|
Renal Group
Severe
|
0 Participants
n=151 Participants • Number of subjects with observation at baseline.
|
0 Participants
n=50 Participants • Number of subjects with observation at baseline.
|
0 Participants
n=201 Participants • Number of subjects with observation at baseline.
|
|
Renal Group
ESRD
|
0 Participants
n=151 Participants • Number of subjects with observation at baseline.
|
0 Participants
n=50 Participants • Number of subjects with observation at baseline.
|
0 Participants
n=201 Participants • Number of subjects with observation at baseline.
|
|
Weight
|
80.8 Kilograms
STANDARD_DEVIATION 14.77 • n=154 Participants
|
80.4 Kilograms
STANDARD_DEVIATION 12.93 • n=51 Participants
|
80.7 Kilograms
STANDARD_DEVIATION 14.30 • n=205 Participants
|
|
Height
|
169.9 Centimeters
STANDARD_DEVIATION 10.17 • n=154 Participants
|
168.3 Centimeters
STANDARD_DEVIATION 9.99 • n=51 Participants
|
169.5 Centimeters
STANDARD_DEVIATION 10.12 • n=205 Participants
|
|
BMI
|
27.9 kilograms/meters^2
STANDARD_DEVIATION 3.71 • n=154 Participants
|
28.3 kilograms/meters^2
STANDARD_DEVIATION 3.49 • n=51 Participants
|
28.0 kilograms/meters^2
STANDARD_DEVIATION 3.65 • n=205 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose) to 4 hours after the start of infusionReversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo
Outcome measures
| Measure |
Bentracimab (PB2452)
n=154 Participants
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion: Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
|
Placebo
n=51 Participants
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Placebo (0.9% Sodium chloride) infusion: 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
|
|---|---|---|
|
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.
|
-5.99 Percent Inhibition of PRU Over 4 Hours
Interval -8.55 to -3.43
|
90.11 Percent Inhibition of PRU Over 4 Hours
Interval 86.24 to 93.98
|
Adverse Events
Bentracimab (PB2452)
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bentracimab (PB2452)
n=154 participants at risk
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion: Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
|
Placebo
n=51 participants at risk
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Placebo (0.9% Sodium chloride) infusion: 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
Other adverse events
| Measure |
Bentracimab (PB2452)
n=154 participants at risk
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion: Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
|
Placebo
n=51 participants at risk
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Ticagrelor Oral Tablet - Pre-Treatment: Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment: Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Placebo (0.9% Sodium chloride) infusion: 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
5/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
3.9%
2/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Infections and infestations
Asymptomatic COVID-19
|
1.3%
2/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Infections and infestations
COVID-19
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
3.9%
2/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.9%
6/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
3.9%
2/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Flushing
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Haematoma
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Hot flush
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Phlebitis
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Thrombophlebitis
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Investigations
Occult blood
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Investigations
Occult blood positive
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Vessel puncture site bruise
|
2.6%
4/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Oedema
|
1.3%
2/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Catheter site bruise
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Infusion site extravasation
|
1.3%
2/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Administration site bruise
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Catheter site haemorrhage
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Catheter site oedema
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Chest discomfort
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Chest pain
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Crepitations
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Fatigue
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Infusion site bruising
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Infusion site erythema
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Infusion site pruritus
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Infusion site reaction
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Injection site haemorrhage
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Injection site phlebitis
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Injection site reaction
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Pain
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Thirst
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
General disorders
Vessel puncture site erythema
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Nervous system disorders
Headache
|
3.9%
6/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
7.8%
4/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Nervous system disorders
Dizziness
|
1.3%
2/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
3/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
3.9%
2/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
3.9%
2/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
0.00%
0/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/154 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
2.0%
1/51 • Through End of Study Visit (Day 35)
Serious Adverse Events (SAEs) and Adverse Events (AEs) reported for Safety Subset which includes subjects who received any amount of study drug; 2 subjects randomized in error and did not receive study drug. Subjects could spontaneously report and/or were asked a standard question to elicit any medically related changes in well-being. Changes in lab values, physical exam findings, 12-lead ECG monitoring changes, or other events relevant to subject safety were assessed and reported as an AE.
|
Additional Information
Michele LaRussa SVP, Chief Regulatory Officer
SFJ Pharmaceuticals, Inc.
Phone: 925-223-6233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place