Trial Outcomes & Findings for Effects of Metformin in a Non-Diabetic Patient Population (NCT NCT03772964)
NCT ID: NCT03772964
Last Updated: 2023-01-11
Results Overview
Venous blood samples will be gathered throughout the study in order to quantify the changes in cytokine expression (FN-γ, IL-10, IL12p40, IL-12p70, IL-1α, IL1β, IL-2, IL-6, IL-8, IP-10, MCP-1, MIP-1α, MIP-1β, TNF-α) following ex vivo PBMC exposure to endotoxin.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)
Results posted on
2023-01-11
Participant Flow
Participant milestones
| Measure |
500mg Exposure
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
Subjects will be exposed to placebo for up to 90 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Metformin in a Non-Diabetic Patient Population
Baseline characteristics by cohort
| Measure |
500mg Exposure
n=8 Participants
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 Participants
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 Participants
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 Participants
Subjects will be exposed to placebo for up to 90 days.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 6 • n=5 Participants
|
70 years
STANDARD_DEVIATION 6 • n=7 Participants
|
71 years
STANDARD_DEVIATION 4 • n=5 Participants
|
68 years
STANDARD_DEVIATION 6 • n=4 Participants
|
70 years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: Samples collected. Results were not yielded as they were not adequate to run samples with the available staffing.
Venous blood samples will be gathered throughout the study in order to quantify the changes in cytokine expression (FN-γ, IL-10, IL12p40, IL-12p70, IL-1α, IL1β, IL-2, IL-6, IL-8, IP-10, MCP-1, MIP-1α, MIP-1β, TNF-α) following ex vivo PBMC exposure to endotoxin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Bacterial communities using 16S rRNA sequencing in relationship to metformin dosing over time. Species richness or diversity in the sample is measured by Choa1 metric. Chao1 is an estimate of how many species are present in an ecosystem. In general, having more species is considered to be "healthier" and these values typically range from 100-200 for fecal samples. The Chao1 index over numerous samples across time are explored to understand treatment effects.
Outcome measures
| Measure |
500mg Exposure
n=8 Participants
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 Participants
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 Participants
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 Participants
Subjects will be exposed to placebo for up to 90 days.
Placebo: Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
|---|---|---|---|---|
|
Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples.
Day 0
|
136.5 Index
Standard Deviation 19.0
|
107.6 Index
Standard Deviation 13.3
|
128.1 Index
Standard Deviation 10.5
|
141.5 Index
Standard Deviation 15
|
|
Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples.
Day 30
|
139.9 Index
Standard Deviation 16.2
|
130.7 Index
Standard Deviation 19.4
|
128.1 Index
Standard Deviation 13.2
|
144.75 Index
Standard Deviation 13.2
|
|
Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples.
Day 60
|
121.4 Index
Standard Deviation 20.8
|
137.9 Index
Standard Deviation 17.7
|
128.6 Index
Standard Deviation 12.7
|
134.3 Index
Standard Deviation 9.8
|
|
Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples.
Day 90
|
137.8 Index
Standard Deviation 27.8
|
135 Index
Standard Deviation 18.9
|
138.2 Index
Standard Deviation 10.3
|
152 Index
Standard Deviation 20.5
|
|
Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples.
Day 120
|
134 Index
Standard Deviation 23.6
|
142.2 Index
Standard Deviation 17.3
|
144.2 Index
Standard Deviation 16.5
|
159.2 Index
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: Samples were collected and processed at each time point for each participant. When sample processing did not yeild any result (processing failure) no data could be yeilded and therefore can not be presented.
Aggregometry area under the curve with the Y-axis being % aggregometry and the X-axis time in minutes.
Outcome measures
| Measure |
500mg Exposure
n=8 Participants
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 Participants
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 Participants
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 Participants
Subjects will be exposed to placebo for up to 90 days.
Placebo: Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
|---|---|---|---|---|
|
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen.
0 days
|
56.3 arbitrary units*mins
Standard Deviation 40
|
67 arbitrary units*mins
Standard Deviation 38
|
196 arbitrary units*mins
Standard Deviation 376
|
83.3 arbitrary units*mins
Standard Deviation 69
|
|
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen.
30 day change from day 0
|
-34.7 arbitrary units*mins
Standard Deviation 24.5
|
8.9 arbitrary units*mins
Standard Deviation 50.1
|
-166.7 arbitrary units*mins
Standard Deviation 409
|
-29.6 arbitrary units*mins
Standard Deviation 104.8
|
|
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen.
60 days change from day 0
|
-28.3 arbitrary units*mins
Standard Deviation 54
|
-23.5 arbitrary units*mins
Standard Deviation 44.5
|
-139.8 arbitrary units*mins
Standard Deviation 376.3
|
-49.4 arbitrary units*mins
Standard Deviation 86.7
|
|
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen.
90 days change from day 0
|
1.6 arbitrary units*mins
Standard Deviation 57.6
|
2.4 arbitrary units*mins
Standard Deviation 84.5
|
-222.5 arbitrary units*mins
Standard Deviation 456.2
|
-66.6 arbitrary units*mins
Standard Deviation 102.6
|
|
Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen.
120 days change from day 0
|
-49.2 arbitrary units*mins
Standard Deviation 84.2
|
1.0 arbitrary units*mins
Standard Deviation 28.9
|
-196.7 arbitrary units*mins
Standard Deviation 410.6
|
-47.6 arbitrary units*mins
Standard Deviation 103.0
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: These data were not able to be collected due to storage issues and lab shutdowns during the COVID-19 pandemic.
The endpoints for isolated platelets include platelet activation as measured by FACS for CD62p.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 (baseline), 90, and 120 (30 days post metformin exposure)Population: Notably, one patient in the 500mg and 1000mg group was unable to finish the 120d testing secondary to COVID-19 limitations.
The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The minimum is zero (worse performance) and the maximum is 12 (best performance).
Outcome measures
| Measure |
500mg Exposure
n=8 Participants
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 Participants
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 Participants
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 Participants
Subjects will be exposed to placebo for up to 90 days.
Placebo: Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
|---|---|---|---|---|
|
Changes From Baseline in Short Physical Performance Battery (SPPB) During and Following Exposure to Metformin.
0d
|
11.2 Units on a scale
Standard Deviation .9
|
10.8 Units on a scale
Standard Deviation 1.3
|
11.1 Units on a scale
Standard Deviation 0.9
|
10.6 Units on a scale
Standard Deviation 1.3
|
|
Changes From Baseline in Short Physical Performance Battery (SPPB) During and Following Exposure to Metformin.
90d, change from 0d
|
-0.3 Units on a scale
Standard Deviation 1.4
|
0.4 Units on a scale
Standard Deviation 0.7
|
0.4 Units on a scale
Standard Deviation 0.5
|
1.0 Units on a scale
Standard Deviation 1.0
|
|
Changes From Baseline in Short Physical Performance Battery (SPPB) During and Following Exposure to Metformin.
120d, change from 0d
|
0 Units on a scale
Standard Deviation 0.6
|
0.2 Units on a scale
Standard Deviation 1.0
|
0.3 Units on a scale
Standard Deviation 1.3
|
0.5 Units on a scale
Standard Deviation .8
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 90, and 120 (30 days post metformin exposure)Population: Notably, one patient in the 500mg and 1000mg group was unable to finish the 120d testing secondary to COVID-19 limitations.
Grip strength over time.
Outcome measures
| Measure |
500mg Exposure
n=8 Participants
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 Participants
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 Participants
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 Participants
Subjects will be exposed to placebo for up to 90 days.
Placebo: Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
|---|---|---|---|---|
|
Changes From Baseline in Grip Strength Via a Dynamometer During and Following Exposure to Metformin.
0 days
|
28.2 mmHg
Standard Deviation 10.3
|
28.9 mmHg
Standard Deviation 8.3
|
25.7 mmHg
Standard Deviation 7.8
|
25.7 mmHg
Standard Deviation 9.2
|
|
Changes From Baseline in Grip Strength Via a Dynamometer During and Following Exposure to Metformin.
90 days, compared to 0 days
|
-5.3 mmHg
Standard Deviation 12.5
|
-0.4 mmHg
Standard Deviation 3.1
|
-.2 mmHg
Standard Deviation 2.1
|
-.3 mmHg
Standard Deviation 3.5
|
|
Changes From Baseline in Grip Strength Via a Dynamometer During and Following Exposure to Metformin.
120 days, compared to 0 days
|
.1 mmHg
Standard Deviation 4.8
|
1.1 mmHg
Standard Deviation 2.7
|
.3 mmHg
Standard Deviation 3.0
|
-.6 mmHg
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: Samples were collected. Cell processing did not allow for the analysis of any data from collected samples. No data were therefore able to be collected.
Oxidative phosphorylation, respiration, and complex activity will be tested using an Oroboros respirometer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: Samples were collected. Cell processing did not allow for the analysis of any data from collected samples. No data were therefore able to be collected.
Mitochondrial content will be measured by staining for mitotracker, and mitochondrial DNA oxidation will be determined by co-localizing staining for 8-hydroxydeoxyguanosine (8-OHdG). Markers of autophagy will be determined by measuring LC-3 flux, p62, beclin-1, and ATG7 protein levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)Population: Samples were collected. Cell processing did not allow for the analysis of any data from collected samples. No data were therefore able to be collected.
Biogenesis will be determined by measuring RNA for PGC1a, NRF-1, and Tfam.
Outcome measures
Outcome data not reported
Adverse Events
500mg Exposure
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1000mg Exposure
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1500mg Exposure
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
500mg Exposure
n=8 participants at risk
Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1000mg Exposure
n=8 participants at risk
Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
1500mg Exposure
n=8 participants at risk
Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.
MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
|
Placebo
n=8 participants at risk
Subjects will be exposed to placebo for up to 90 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
62.5%
5/8 • Number of events 5 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
12.5%
1/8 • Number of events 1 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
50.0%
4/8 • Number of events 4 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
62.5%
5/8 • Number of events 5 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/8 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
|
Musculoskeletal and connective tissue disorders
Joint pain or fracture
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
0.00%
0/8 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
25.0%
2/8 • Number of events 2 • Adverse events were monitored from the time of randomization for 120 days.
Unexpected serious adverse events including significant illness, hospitalization, emergent or urgent surgery or procedure, psychiatric hospitalization or inpatient rehabilitation, would require the study team to discontinue the subject's participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place