Aging
Conditions
Keywords
Prehabilitation
Brief summary
The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted. The structure of this project permits: * the testing of multiple treatments at the same time within the same patient * the use of early study results to provide better treatment options to future patients * the removal of treatments which are shown to be less effective than the other treatments * the addition of new treatments The first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038). The SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.
Interventions
DRUGMetformin ER
tablet
DRUGPlacebo
Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
Sponsors
University of Pittsburgh Medical Center
Berry Consultants
Matthew Neal MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
UPMC REMAP Inclusion Criteria: * Adult patient evaluated pre-operatively for elective surgery at UPMC * Minimum lead time before surgery to provide domain specific intervention (range 7-180 days pre-operatively) * Age greater to or equal to 18 years of age
Exclusion criteria
* Death is deemed to be imminent or inevitable * Emergency surgical procedure without suitable lead-in time * Previous participation in this REMAP within the last 90 days, flagged by elective or emergency surgical encounter at UPMC in the past 90 days SPRY Domain Inclusion Criteria: * Age \>= 60 years * Age \< 60 but evidence of comorbidity risk as represented by a Charlson Comorbidity Index of \> 2 in 12 months prior to enrollment * Able to take an oral medication in non-crushable pill form * Women must be post-menopausal, which is defined as not having a menstrual period within the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Free Days (HFD) | Day 90 from the date of the elective surgical procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Total Number of Reoperation/Reintervention | Day 90 from the date of the elective surgical procedure | 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 |
| Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | Day 90 from the date of the elective surgical procedure | 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 |
| Number of Participants With Surgical Site Infection | Day 30 from the date of the elective surgical procedure | — |
| Number of Participants With Surgical Site Occurrence | Day 30 from the date of the elective surgical procedure | — |
| Organ Failure Free Days | Day 30 from the date of the elective surgical procedure | — |
| Hospital Length of Stay (LOS) | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days | — |
| Incidence of ICU Admission After Surgery | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed | 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. |
| Mortality | Day 90 from the date of the elective surgical procedure | — |
| Hospital Readmission Rate | Day 90 from the date of the elective surgical procedure | — |
| Gastrointestinal Intolerance | From enrollment to day 90 after surgery | — |
| SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | From enrollment to day 90 after surgery | 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 |
| Discharge Disposition | 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 | — |
| In Hospital Mortality | 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. | — |
| ICU (Intensive Care Unit) Length of Stay (LOS) | 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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 | 20 |
| 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 | 5 |
| 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 | 39 |
| 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 | 19 |
| 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 | 8 |
| 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 | 40 |
| 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 | 26 |
| 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 | 0 |
| 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. | 106 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 5 | 2 | 1 | 3 | 1 | 0 | 5 |
Baseline characteristics
| Characteristic | SPRY: Metformin LD-LC (Low-dose, Long Course) | SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | SPRY: Metformin HD-SC (High-dose, Short Course) | SPRY: Metformin LD-SC (Low-dose, Short Course) | SPRY: Metformin HD-IC (High-dose, Intermediate Course) | SPRY: Metformin HD-LC (High-dose, Long Course) | SPRY: Placebo | SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 23 Participants | 12 Participants | 7 Participants | 26 Participants | 26 Participants | 23 Participants | 0 Participants | 69 Participants | 16 Participants | 207 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 16 Participants | 7 Participants | 1 Participants | 14 Participants | 13 Participants | 3 Participants | 0 Participants | 37 Participants | 4 Participants | 95 Participants |
| Age, Continuous | 70.8 years STANDARD_DEVIATION 5.1 | 67.7 years STANDARD_DEVIATION 7.3 | 68.6 years STANDARD_DEVIATION 8.4 | 71.1 years STANDARD_DEVIATION 5.8 | 67.5 years STANDARD_DEVIATION 8.2 | 68.9 years STANDARD_DEVIATION 6.9 | 70.2 years STANDARD_DEVIATION 6.5 | — | 67.8 years STANDARD_DEVIATION 5.7 | 69.0 years STANDARD_DEVIATION 6.1 | 68.4 years STANDARD_DEVIATION 6.7 |
| Body Mass Index (BMI) | 31.3 kg/m^2 STANDARD_DEVIATION 4.2 | 30.9 kg/m^2 STANDARD_DEVIATION 5.9 | 28.0 kg/m^2 STANDARD_DEVIATION 4.6 | 26.2 kg/m^2 STANDARD_DEVIATION 5.1 | 30.5 kg/m^2 STANDARD_DEVIATION 10.7 | 30.9 kg/m^2 STANDARD_DEVIATION 5.5 | 30.6 kg/m^2 STANDARD_DEVIATION 6.6 | — | 30.2 kg/m^2 STANDARD_DEVIATION 6.4 | 30.9 kg/m^2 STANDARD_DEVIATION 4.7 | 30.3 kg/m^2 STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 37 Participants | 19 Participants | 8 Participants | 39 Participants | 38 Participants | 25 Participants | 0 Participants | 106 Participants | 19 Participants | 295 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants |
| History of chronic obstructive pulmonary disease No | 4 Participants | 34 Participants | 19 Participants | 7 Participants | 37 Participants | 38 Participants | 21 Participants | 0 Participants | 94 Participants | 19 Participants | 273 Participants |
| History of chronic obstructive pulmonary disease Yes | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 5 Participants | 0 Participants | 12 Participants | 1 Participants | 29 Participants |
| History of congestive heart failure No | 5 Participants | 38 Participants | 19 Participants | 8 Participants | 39 Participants | 38 Participants | 26 Participants | 0 Participants | 104 Participants | 20 Participants | 297 Participants |
| History of congestive heart failure Yes | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 5 Participants |
| History of coronary artery disease No | 5 Participants | 35 Participants | 16 Participants | 7 Participants | 34 Participants | 33 Participants | 22 Participants | 0 Participants | 91 Participants | 18 Participants | 261 Participants |
| History of coronary artery disease Yes | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 6 Participants | 6 Participants | 4 Participants | 0 Participants | 15 Participants | 2 Participants | 41 Participants |
| History of Stroke No | 3 Participants | 37 Participants | 17 Participants | 8 Participants | 40 Participants | 38 Participants | 26 Participants | 0 Participants | 102 Participants | 20 Participants | 291 Participants |
| History of Stroke Yes | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 5 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 4 Participants | 33 Participants | 18 Participants | 8 Participants | 39 Participants | 38 Participants | 21 Participants | 0 Participants | 101 Participants | 17 Participants | 279 Participants |
| Risk analysis index score | 31.0 units on a scale STANDARD_DEVIATION 13.5 | 25.6 units on a scale STANDARD_DEVIATION 5.5 | 22.8 units on a scale STANDARD_DEVIATION 3.5 | 24.2 units on a scale STANDARD_DEVIATION 2.3 | 25.5 units on a scale STANDARD_DEVIATION 7.4 | 27.2 units on a scale STANDARD_DEVIATION 6.9 | 26.1 units on a scale STANDARD_DEVIATION 4.6 | — | 25.8 units on a scale STANDARD_DEVIATION 6.4 | 25.2 units on a scale STANDARD_DEVIATION 5.9 | 25.8 units on a scale STANDARD_DEVIATION 6.3 |
| Sex: Female, Male Female | 3 Participants | 17 Participants | 8 Participants | 2 Participants | 11 Participants | 21 Participants | 14 Participants | 0 Participants | 50 Participants | 8 Participants | 134 Participants |
| Sex: Female, Male Male | 2 Participants | 22 Participants | 11 Participants | 6 Participants | 29 Participants | 18 Participants | 12 Participants | 0 Participants | 56 Participants | 12 Participants | 168 Participants |
| Smoking status Active | 0 Participants | 6 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 7 Participants | 3 Participants | 21 Participants |
| Smoking status Never | 2 Participants | 16 Participants | 13 Participants | 5 Participants | 19 Participants | 23 Participants | 15 Participants | 0 Participants | 50 Participants | 13 Participants | 156 Participants |
| Smoking status Quit | 2 Participants | 17 Participants | 6 Participants | 2 Participants | 18 Participants | 15 Participants | 10 Participants | 0 Participants | 48 Participants | 4 Participants | 122 Participants |
| Smoking status Unknown status | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Surgical strata Colorectal surgery | 1 Participants | 4 Participants | 5 Participants | 0 Participants | 6 Participants | 2 Participants | 2 Participants | 0 Participants | 13 Participants | 3 Participants | 36 Participants |
| Surgical strata General surgery/Oncological surgery | 3 Participants | 10 Participants | 10 Participants | 5 Participants | 12 Participants | 13 Participants | 12 Participants | 0 Participants | 33 Participants | 9 Participants | 107 Participants |
| Surgical strata No operation | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 0 Participants | 8 Participants | 0 Participants | 20 Participants |
| Surgical strata Other | 0 Participants | 12 Participants | 1 Participants | 2 Participants | 8 Participants | 11 Participants | 3 Participants | 0 Participants | 18 Participants | 2 Participants | 57 Participants |
| Surgical strata Spine surgery | 1 Participants | 9 Participants | 3 Participants | 1 Participants | 12 Participants | 10 Participants | 6 Participants | 0 Participants | 34 Participants | 6 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 20 | 0 / 5 | 1 / 39 | 0 / 19 | 0 / 8 | 0 / 40 | 0 / 26 | 0 / 0 | 0 / 106 |
| other Total, other adverse events | 10 / 39 | 5 / 20 | 2 / 5 | 9 / 39 | 5 / 19 | 2 / 8 | 11 / 40 | 3 / 26 | 0 / 0 | 10 / 106 |
| serious Total, serious adverse events | 11 / 39 | 5 / 20 | 2 / 5 | 10 / 39 | 6 / 19 | 2 / 8 | 12 / 40 | 4 / 26 | 0 / 0 | 12 / 106 |
Outcome results
Primary
Hospital Free Days (HFD)
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.
Time frame: Day 90 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-treat analysis. Participants that did not undergo an operation were excluded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Hospital Free Days (HFD) | 87 Days |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Hospital Free Days (HFD) | 88.5 Days |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Hospital Free Days (HFD) | 85 Days |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Hospital Free Days (HFD) | 88 Days |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Hospital Free Days (HFD) | 88 Days |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Hospital Free Days (HFD) | 89.5 Days |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Hospital Free Days (HFD) | 88 Days |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Hospital Free Days (HFD) | 87 Days |
| SPRY: Placebo | Hospital Free Days (HFD) | 87 Days |
Comparison: Low dose groups collapsed and compared to placebo95% CI: [0.67, 1.97]
Comparison: Intermediate dose groups were collapsed and compared to placebo95% CI: [0.42, 1.25]
Comparison: High dose groups were collapsed and compared to placebo95% CI: [0.61, 1.84]
Secondary
Discharge Disposition
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Discharge Disposition | Missing data | 2 Participants |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 5 Participants |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Discharge Disposition | Home | 29 Participants |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Discharge Disposition | Home | 18 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Discharge Disposition | Missing data | 1 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 1 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Discharge Disposition | Home | 5 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Discharge Disposition | Missing data | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Discharge Disposition | Missing data | 4 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Discharge Disposition | Home | 30 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 1 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Discharge Disposition | Home | 17 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Discharge Disposition | Missing data | 2 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Discharge Disposition | Missing data | 1 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Discharge Disposition | Home | 7 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Discharge Disposition | Missing data | 3 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 2 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Discharge Disposition | Home | 33 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 4 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Discharge Disposition | Home | 18 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Discharge Disposition | Missing data | 1 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Discharge Disposition | Missing data | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Discharge Disposition | Home | 0 Participants |
| SPRY: Placebo | Discharge Disposition | Death/Hospice | 0 Participants |
| SPRY: Placebo | Discharge Disposition | Home | 85 Participants |
| SPRY: Placebo | Discharge Disposition | Missing data | 5 Participants |
| SPRY: Placebo | Discharge Disposition | Skilled nursing facility/Rehabilitation facility | 8 Participants |
Comparison: All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.p-value: 0.7295% CI: [0.52, 1.56]Regression, Logistic
Secondary
Gastrointestinal Intolerance
Time frame: From enrollment to day 90 after surgery
Population: All participants included. Group with zero participants added for completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Gastrointestinal Intolerance | 7 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Gastrointestinal Intolerance | 4 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Gastrointestinal Intolerance | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Gastrointestinal Intolerance | 4 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Gastrointestinal Intolerance | 5 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Gastrointestinal Intolerance | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Gastrointestinal Intolerance | 6 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Gastrointestinal Intolerance | 3 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Gastrointestinal Intolerance | 0 Participants |
| SPRY: Placebo | Gastrointestinal Intolerance | 6 Participants |
Comparison: All intervention groups were collapsed and compared to placebop-value: 0.0195% CI: [1.19, 7.44]Regression, Logistic
Secondary
Hospital Length of Stay (LOS)
Time frame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Hospital Length of Stay (LOS) | 3.9 Days | Standard Deviation 4.9 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Hospital Length of Stay (LOS) | 2.5 Days | Standard Deviation 2.8 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Hospital Length of Stay (LOS) | 4.00 Days | Standard Deviation 2.3 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Hospital Length of Stay (LOS) | 3.6 Days | Standard Deviation 4.1 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Hospital Length of Stay (LOS) | 2.6 Days | Standard Deviation 3.4 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Hospital Length of Stay (LOS) | 0.4 Days | Standard Deviation 0.5 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Hospital Length of Stay (LOS) | 4.3 Days | Standard Deviation 6.7 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Hospital Length of Stay (LOS) | 3.3 Days | Standard Deviation 3.2 |
| SPRY: Placebo | Hospital Length of Stay (LOS) | 4.2 Days | Standard Deviation 7.4 |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.3Regression, Linear
Secondary
Hospital Readmission Rate
Time frame: Day 90 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Hospital Readmission Rate | 5 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Hospital Readmission Rate | 2 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Hospital Readmission Rate | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Hospital Readmission Rate | 6 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Hospital Readmission Rate | 3 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Hospital Readmission Rate | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Hospital Readmission Rate | 5 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Hospital Readmission Rate | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Hospital Readmission Rate | 0 Participants |
| SPRY: Placebo | Hospital Readmission Rate | 9 Participants |
p-value: 0.2795% CI: [0.74, 2.86]Regression, Logistic
Secondary
ICU (Intensive Care Unit) Length of Stay (LOS)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.1 Days | Standard Deviation 0.4 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.3 Days | Standard Deviation 0.9 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.0 Days | Standard Deviation 0 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.3 Days | Standard Deviation 1.3 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.3 Days | Standard Deviation 0.9 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.1 Days | Standard Deviation 0.3 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.1 Days | Standard Deviation 0.6 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.1 Days | Standard Deviation 0.5 |
| SPRY: Placebo | ICU (Intensive Care Unit) Length of Stay (LOS) | 0.2 Days | Standard Deviation 0.7 |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.65Regression, Linear
Secondary
Incidence and Total Number of Reoperation/Reintervention
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
Time frame: Day 90 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Incidence and Total Number of Reoperation/Reintervention | 8 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Incidence and Total Number of Reoperation/Reintervention | 1 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Incidence and Total Number of Reoperation/Reintervention | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Incidence and Total Number of Reoperation/Reintervention | 1 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Incidence and Total Number of Reoperation/Reintervention | 1 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Incidence and Total Number of Reoperation/Reintervention | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Incidence and Total Number of Reoperation/Reintervention | 1 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Incidence and Total Number of Reoperation/Reintervention | 1 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Incidence and Total Number of Reoperation/Reintervention | 0 Participants |
| SPRY: Placebo | Incidence and Total Number of Reoperation/Reintervention | 14 Participants |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.895% CI: [0.52, 2]Regression, Logistic
Secondary
Incidence of ICU Admission After Surgery
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.
Time frame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed
Population: Participants analyzed using intention-to-treat analysis. Participants that did not undergo surgery were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Incidence of ICU Admission After Surgery | 3 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Incidence of ICU Admission After Surgery | 2 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Incidence of ICU Admission After Surgery | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Incidence of ICU Admission After Surgery | 3 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Incidence of ICU Admission After Surgery | 2 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Incidence of ICU Admission After Surgery | 1 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Incidence of ICU Admission After Surgery | 3 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Incidence of ICU Admission After Surgery | 1 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Incidence of ICU Admission After Surgery | 0 Participants |
| SPRY: Placebo | Incidence of ICU Admission After Surgery | 10 Participants |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.9295% CI: [0.52, 2.03]Regression, Logistic
Secondary
In Hospital Mortality
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | In Hospital Mortality | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | In Hospital Mortality | 0 Participants |
| SPRY: Placebo | In Hospital Mortality | 0 Participants |
Secondary
Mortality
Time frame: Day 90 from the date of the elective surgical procedure
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Mortality | 0 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Mortality | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Mortality | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Mortality | 1 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Mortality | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Mortality | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Mortality | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Mortality | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Mortality | 0 Participants |
| SPRY: Placebo | Mortality | 0 Participants |
Secondary
Number of Participants With Surgical Site Infection
Time frame: Day 30 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Number of Participants With Surgical Site Infection | 2 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Number of Participants With Surgical Site Infection | 2 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Number of Participants With Surgical Site Infection | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Number of Participants With Surgical Site Infection | 3 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Number of Participants With Surgical Site Infection | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Number of Participants With Surgical Site Infection | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Number of Participants With Surgical Site Infection | 1 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Number of Participants With Surgical Site Infection | 2 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Number of Participants With Surgical Site Infection | 0 Participants |
| SPRY: Placebo | Number of Participants With Surgical Site Infection | 4 Participants |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.2395% CI: [0.73, 3.62]Regression, Logistic
Secondary
Number of Participants With Surgical Site Occurrence
Time frame: Day 30 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Number of Participants With Surgical Site Occurrence | 3 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Number of Participants With Surgical Site Occurrence | 2 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Number of Participants With Surgical Site Occurrence | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Number of Participants With Surgical Site Occurrence | 3 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Number of Participants With Surgical Site Occurrence | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Number of Participants With Surgical Site Occurrence | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Number of Participants With Surgical Site Occurrence | 5 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Number of Participants With Surgical Site Occurrence | 5 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Number of Participants With Surgical Site Occurrence | 0 Participants |
| SPRY: Placebo | Number of Participants With Surgical Site Occurrence | 8 Participants |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.3195% CI: [0.71, 2.86]Regression, Logistic
Secondary
Organ Failure Free Days
Time frame: Day 30 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Organ Failure Free Days | 29.84 Days | Standard Error 0.53 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Organ Failure Free Days | 29.93 Days | Standard Error 0.22 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Organ Failure Free Days | 29.97 Days | Standard Error 0.03 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Organ Failure Free Days | 29.96 Days | Standard Error 0.04 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Organ Failure Free Days | 29.86 Days | Standard Error 0.32 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Organ Failure Free Days | 29.98 Days | Standard Error 0.02 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Organ Failure Free Days | 29.88 Days | Standard Error 0.5 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Organ Failure Free Days | 29.94 Days | Standard Error 0.21 |
| SPRY: Placebo | Organ Failure Free Days | 29.90 Days | Standard Error 0.27 |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.97Regression, Linear
Secondary
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
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
Time frame: From enrollment to day 90 after surgery
Population: All participants included. Group with zero participants included for completion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 2 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 1 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - related | 1 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 | 0 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 2 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 1 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 2 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 1 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - related | 2 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Severe - unrelated | 2 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - related | 2 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 0 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 1 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - related | 2 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 0 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 2 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | 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 | 1 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 | 0 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | 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 |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 1 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 5 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 2 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Severe - unrelated | 1 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 2 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | 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 |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - related | 1 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 4 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - related | 1 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 2 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | 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 | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | 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 |
| SPRY: Metformin HD-LC (High-dose, Long Course) | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 0 Participants |
| SPRY: Placebo | 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 |
| SPRY: Placebo | 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 |
| SPRY: Placebo | 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 |
| SPRY: Placebo | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild- possibly related | 4 Participants |
| SPRY: Placebo | 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 |
| SPRY: Placebo | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - unrelated | 3 Participants |
| SPRY: Placebo | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate - unrelated | 3 Participants |
| SPRY: Placebo | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Mild - related | 2 Participants |
| SPRY: Placebo | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | Moderate- possibly related | 0 Participants |
| SPRY: Placebo | 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 |
| SPRY: Placebo | 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 |
| SPRY: Placebo | 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 | 1 Participants |
Comparison: All intervention groups were collapsed and compared to placebop-value: <0.0195% CI: [1.34, 5.3]Regression, Logistic
Secondary
Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism
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
Time frame: Day 90 from the date of the elective surgical procedure
Population: Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPRY: Metformin LD-SC (Low-dose, Short Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 1 Participants |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 1 Participants |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin HD-SC (High-dose, Short Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Metformin HD-LC (High-dose, Long Course) | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 0 Participants |
| SPRY: Placebo | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | 2 Participants |
Comparison: All intervention groups were grouped together and compared to placebop-value: 0.6595% CI: [0.49, 3.11]Regression, Logistic