Trial Outcomes & Findings for REMAP Trial for Optimizing Surgical Outcomes at UPMC (NCT NCT03861767)
NCT ID: NCT03861767
Last Updated: 2024-06-18
Results Overview
90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Day 90 from the date of the elective surgical procedure
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
20
|
5
|
39
|
19
|
8
|
40
|
26
|
0
|
106
|
|
Overall Study
Underwent Surgery
|
36
|
20
|
5
|
35
|
19
|
8
|
38
|
23
|
0
|
98
|
|
Overall Study
Drug Compliance
|
34
|
19
|
4
|
37
|
15
|
8
|
35
|
21
|
0
|
95
|
|
Overall Study
COMPLETED
|
37
|
19
|
5
|
34
|
17
|
7
|
37
|
25
|
0
|
101
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
5
|
2
|
1
|
3
|
1
|
0
|
5
|
Reasons for withdrawal
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
5
|
2
|
1
|
3
|
1
|
0
|
5
|
Baseline Characteristics
REMAP Trial for Optimizing Surgical Outcomes at UPMC
Baseline characteristics by cohort
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=39 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=39 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=40 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=26 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=106 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
37 Participants
|
95 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
69 Participants
|
207 Participants
n=19 Participants
|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
69.0 years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
70.8 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
67.7 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 8.4 • n=31 Participants
|
71.1 years
STANDARD_DEVIATION 5.8 • n=30 Participants
|
67.5 years
STANDARD_DEVIATION 8.2 • n=3 Participants
|
70.2 years
STANDARD_DEVIATION 6.5 • n=6 Participants
|
—
|
67.8 years
STANDARD_DEVIATION 5.7
|
68.4 years
STANDARD_DEVIATION 6.7 • n=19 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
50 Participants
|
134 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
56 Participants
|
168 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
106 Participants
|
295 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
6 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
4 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
5 Participants
|
15 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
101 Participants
|
279 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
4 Participants
n=19 Participants
|
|
Body Mass Index (BMI)
|
30.9 kg/m^2
STANDARD_DEVIATION 5.5 • n=99 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 4.7 • n=107 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=206 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.6 • n=31 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=30 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 10.7 • n=3 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=6 Participants
|
—
|
30.2 kg/m^2
STANDARD_DEVIATION 6.4
|
30.3 kg/m^2
STANDARD_DEVIATION 6.7 • n=19 Participants
|
|
Risk analysis index score
|
27.2 units on a scale
STANDARD_DEVIATION 6.9 • n=99 Participants
|
25.2 units on a scale
STANDARD_DEVIATION 5.9 • n=107 Participants
|
31.0 units on a scale
STANDARD_DEVIATION 13.5 • n=206 Participants
|
25.6 units on a scale
STANDARD_DEVIATION 5.5 • n=7 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 3.5 • n=31 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 2.3 • n=30 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 7.4 • n=3 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 4.6 • n=6 Participants
|
—
|
25.8 units on a scale
STANDARD_DEVIATION 6.4
|
25.8 units on a scale
STANDARD_DEVIATION 6.3 • n=19 Participants
|
|
Smoking status
Active
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
7 Participants
|
21 Participants
n=19 Participants
|
|
Smoking status
Quit
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
48 Participants
|
122 Participants
n=19 Participants
|
|
Smoking status
Never
|
23 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
50 Participants
|
156 Participants
n=19 Participants
|
|
Smoking status
Unknown status
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
|
History of Stroke
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
11 Participants
n=19 Participants
|
|
History of Stroke
No
|
38 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
40 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
102 Participants
|
291 Participants
n=19 Participants
|
|
History of chronic obstructive pulmonary disease
Yes
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
12 Participants
|
29 Participants
n=19 Participants
|
|
History of chronic obstructive pulmonary disease
No
|
38 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
37 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
94 Participants
|
273 Participants
n=19 Participants
|
|
History of coronary artery disease
Yes
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
15 Participants
|
41 Participants
n=19 Participants
|
|
History of coronary artery disease
No
|
33 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
91 Participants
|
261 Participants
n=19 Participants
|
|
History of congestive heart failure
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
5 Participants
n=19 Participants
|
|
History of congestive heart failure
No
|
38 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
104 Participants
|
297 Participants
n=19 Participants
|
|
Surgical strata
No operation
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
8 Participants
|
20 Participants
n=19 Participants
|
|
Surgical strata
Spine surgery
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
34 Participants
|
82 Participants
n=19 Participants
|
|
Surgical strata
General surgery/Oncological surgery
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
33 Participants
|
107 Participants
n=19 Participants
|
|
Surgical strata
Colorectal surgery
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
13 Participants
|
36 Participants
n=19 Participants
|
|
Surgical strata
Other
|
11 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
18 Participants
|
57 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 90 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-treat analysis. Participants that did not undergo an operation were excluded.
90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD.
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hospital Free Days (HFD)
|
87 Days
Interval 84.8 to 89.2
|
88.5 Days
Interval 86.8 to 90.0
|
85 Days
Interval 84.0 to 85.0
|
88 Days
Interval 85.0 to 90.0
|
88 Days
Interval 86.5 to 90.0
|
89.5 Days
Interval 89.0 to 90.0
|
88 Days
Interval 85.0 to 90.0
|
87 Days
Interval 84.0 to 90.0
|
—
|
87 Days
Interval 85.0 to 90.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is neededPopulation: Participants analyzed using intention-to-treat analysis. Participants that did not undergo surgery were excluded
The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group.
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of ICU Admission After Surgery
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 90 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Total Number of Reoperation/Reintervention
|
8 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 90 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 30 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Surgical Site Infection
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 30 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Surgical Site Occurrence
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 30 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Organ Failure Free Days
|
29.84 Days
Standard Error 0.53
|
29.93 Days
Standard Error 0.22
|
29.97 Days
Standard Error 0.03
|
29.96 Days
Standard Error 0.04
|
29.86 Days
Standard Error 0.32
|
29.98 Days
Standard Error 0.02
|
29.88 Days
Standard Error 0.50
|
29.94 Days
Standard Error 0.21
|
—
|
29.90 Days
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 daysPopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hospital Length of Stay (LOS)
|
3.9 Days
Standard Deviation 4.9
|
2.5 Days
Standard Deviation 2.8
|
4.00 Days
Standard Deviation 2.3
|
3.6 Days
Standard Deviation 4.1
|
2.6 Days
Standard Deviation 3.4
|
0.4 Days
Standard Deviation 0.5
|
4.3 Days
Standard Deviation 6.7
|
3.3 Days
Standard Deviation 3.2
|
—
|
4.2 Days
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is neededPopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
ICU (Intensive Care Unit) Length of Stay (LOS)
|
0.1 Days
Standard Deviation 0.4
|
0.3 Days
Standard Deviation 0.9
|
0.0 Days
Standard Deviation 0.0
|
0.3 Days
Standard Deviation 1.3
|
0.3 Days
Standard Deviation 0.9
|
0.1 Days
Standard Deviation 0.3
|
0.1 Days
Standard Deviation 0.6
|
0.1 Days
Standard Deviation 0.5
|
—
|
0.2 Days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 90 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. Only one mortality was observed and thus no statistical analysis was performed
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 from the date of the elective surgical procedurePopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hospital Readmission Rate
|
5 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From enrollment to day 90 after surgeryPopulation: All participants included. Group with zero participants added for completion
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=39 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=39 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=40 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=26 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=106 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal Intolerance
|
7 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From enrollment to day 90 after surgeryPopulation: All participants included. Group with zero participants included for completion
The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=39 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=39 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=40 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=26 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=106 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Mild - related
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Mild- possibly related
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Mild - unrelated
|
5 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Moderate - related
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Moderate- possibly related
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Moderate - unrelated
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Severe - related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Severe- possibly related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Severe - unrelated
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
life threatening/disabling - related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
life threatening/disabling - possibly related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
life threatening/disabling - unrelated
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is neededPopulation: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Discharge Disposition
Home
|
29 Participants
|
18 Participants
|
5 Participants
|
30 Participants
|
17 Participants
|
7 Participants
|
33 Participants
|
18 Participants
|
0 Participants
|
85 Participants
|
|
Discharge Disposition
Skilled nursing facility/Rehabilitation facility
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
8 Participants
|
|
Discharge Disposition
Death/Hospice
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discharge Disposition
Missing data
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed.Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. No in-hospital mortalities were observed and hence no statistical analysis was performed
Outcome measures
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=36 Participants
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 Participants
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 Participants
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=35 Participants
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 Participants
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 Participants
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=38 Participants
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=23 Participants
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=98 Participants
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Hospital Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
SPRY: Metformin LD-SC (Low-dose, Short Course)
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
SPRY: Metformin LD-LC (Low-dose, Long Course)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
Serious events: 10 serious events
Other events: 9 other events
Deaths: 1 deaths
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
SPRY: Metformin HD-SC (High-dose, Short Course)
Serious events: 12 serious events
Other events: 11 other events
Deaths: 0 deaths
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
SPRY: Metformin HD-LC (High-dose, Long Course)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SPRY: Placebo
Serious events: 12 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=39 participants at risk
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 participants at risk
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 participants at risk
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=39 participants at risk
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 participants at risk
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 participants at risk
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=40 participants at risk
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=26 participants at risk
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=106 participants at risk
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
From time of prescription until 90 days after surgery
|
5.1%
2/39 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
12.5%
1/8 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
3.8%
1/26 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Hepatobiliary disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Musculoskeletal and connective tissue disorders
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.0%
2/20 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
7.5%
3/40 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
1.9%
2/106 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Immune system disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
General disorders
Time of prescription until 90 days after surgery
|
10.3%
4/39 • Number of events 5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.0%
2/20 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
7.7%
3/39 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Nervous system disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
7.7%
3/39 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
25.0%
2/8 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
1.9%
2/106 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Respiratory, thoracic and mediastinal disorders
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.1%
2/39 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
12.5%
1/8 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
1.9%
2/106 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Blood and lymphatic system disorders
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Gastrointestinal disorders
Time of prescription until 90 days after surgery
|
17.9%
7/39 • Number of events 15 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
4/20 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
1/5 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.3%
4/39 • Number of events 6 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
26.3%
5/19 • Number of events 9 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
15.0%
6/40 • Number of events 12 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
11.5%
3/26 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.7%
6/106 • Number of events 6 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Infections and infestations
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
40.0%
2/5 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Metabolism and nutrition disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Renal and urinary disorders
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
1/5 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Vascular disorders
Time of prescription until 90 days after surgery
|
5.1%
2/39 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
Other adverse events
| Measure |
SPRY: Metformin LD-SC (Low-dose, Short Course)
n=39 participants at risk
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)
n=20 participants at risk
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin LD-LC (Low-dose, Long Course)
n=5 participants at risk
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)
n=39 participants at risk
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)
n=19 participants at risk
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)
n=8 participants at risk
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-SC (High-dose, Short Course)
n=40 participants at risk
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-IC (High-dose, Intermediate Course)
n=26 participants at risk
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Metformin HD-LC (High-dose, Long Course)
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Metformin ER: tablet
|
SPRY: Placebo
n=106 participants at risk
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Time of prescription of study drug until 90 days after surgery
|
17.9%
7/39 • Number of events 15 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
4/20 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
1/5 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.3%
4/39 • Number of events 6 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
26.3%
5/19 • Number of events 9 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
15.0%
6/40 • Number of events 12 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
11.5%
3/26 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.7%
6/106 • Number of events 6 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Blood and lymphatic system disorders
Time of prescription of study drug until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Cardiac disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
12.5%
1/8 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
General disorders
Time of prescription until 90 days after surgery
|
10.3%
4/39 • Number of events 5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.0%
2/20 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
7.7%
3/39 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Hepatobiliary disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Infections and infestations
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
40.0%
2/5 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Injury, poisoning and procedural complications
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.1%
2/39 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Investigations
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Metabolism and nutrition disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Musculoskeletal and connective tissue disorders
Time of prescription until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
10.0%
2/20 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
7.5%
3/40 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
1.9%
2/106 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Nervous system disorders
Time of prescription until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.1%
2/39 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
25.0%
2/8 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
1.9%
2/106 • Number of events 3 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Psychiatric disorders
Time of prescription of study drug until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Renal and urinary disorders
Time of prescription of study drug until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
1/20 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
20.0%
1/5 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Respiratory, thoracic and mediastinal disorders
Time of prescription of study drug until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.1%
2/39 • Number of events 4 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.3%
1/19 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
5.0%
2/40 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.94%
1/106 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Skin and subcutaneous tissue disorders
Time of prescription of study drug until 90 days after surgery
|
2.6%
1/39 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Surgical and medical procedures
Time of prescription of study drug until 90 days after surgery
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
2.5%
1/40 • Number of events 1 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
|
Vascular disorders
Time of prescription of study drug until 90 days after surgery
|
5.1%
2/39 • Number of events 2 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/20 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/5 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/39 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/19 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/8 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/40 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/26 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
—
0/0 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
0.00%
0/106 • From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation. The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place