Trial Outcomes & Findings for Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (NCT NCT04930744)
NCT ID: NCT04930744
Last Updated: 2026-08-06
Results Overview
The cumulative number of participants in each arm experiencing grade 3 or higher adverse events, assessed on every visit from week-1 to week-24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2026-08-06
Participant Flow
Participants were recruited by Tembisa Clinical Research Site (CRS) from primary health care clinics in Ekurhuleni North and the City of Johannesburg. This CRS also recruited through HIV Counseling and Testing program. In addition, participants were recruited by Isango Lethemba TB Research Unit from primary health care clinics in the coastal city of Port Elizabeth. The first participant was enrolled on March 4, 2022, and the last participant was enrolled on November 22, 2024.
Of the 388 participants who were screened, 276 were excluded not meeting inclusion criteria. 112 participants were then randomized to one of two groups, Standard Tuberculosis Medicines or Standard Tuberculosis Medicines and Metformin.
Participant milestones
| Measure |
Standard Tuberculosis Medicines
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Standard Tuberculosis Medicines
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
Baseline characteristics by cohort
| Measure |
Standard Tuberculosis Medicines
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.36 years
STANDARD_DEVIATION 9.28 • n=20 Participants
|
38.50 years
STANDARD_DEVIATION 10.73 • n=20 Participants
|
39.93 years
STANDARD_DEVIATION 10.09 • n=40 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
45 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black/African
|
56 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
108 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White/European
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Marital Status
Single
|
39 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
|
Marital Status
Married
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Marital Status
Cohabitating
|
9 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Body Mass Index
|
22.20 kg/m^2
STANDARD_DEVIATION 5.01 • n=20 Participants
|
21.63 kg/m^2
STANDARD_DEVIATION 4.77 • n=20 Participants
|
21.91 kg/m^2
STANDARD_DEVIATION 4.88 • n=40 Participants
|
|
Tuberculosis Disease Severity
Modest
|
34 participants
n=20 Participants
|
37 participants
n=20 Participants
|
71 participants
n=40 Participants
|
|
Tuberculosis Disease Severity
Severe
|
22 participants
n=20 Participants
|
19 participants
n=20 Participants
|
41 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All enrolled participants.
The cumulative number of participants in each arm experiencing grade 3 or higher adverse events, assessed on every visit from week-1 to week-24.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Number of Participants Experiencing Grade 3 or Higher Adverse Events
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: All participants who had positive sputum culture at baseline
Number of weeks from baseline positive sputum culture to first negative sputum culture measured at every visit by study arm.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=43 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=42 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Time to Sputum Liquid Culture Conversion
|
5 weeks
Interval 3.0 to 7.0
|
5 weeks
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who had chest x-ray score using the Timika Scale at both baseline and 24 weeks
Difference in change in radiographic TB severity measured at baseline and week-24 by study arm. Two blinded readers scored de-identified 1-view chest X-rays using the Timika Scale. Differences in scores were resolved by consensus. The minimum score is 0 and the maximum score is 140, with a score of 140 indicating higher severity. The change in score from baseline to 24 weeks is analyzed by subtracting the baseline score from the 24 week score. High negative magnitude of change indicates greater improvement.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=49 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=47 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in Radiographic Severity Score From Baseline to TB Treatment Completion
|
-39 score on a scale
Interval -46.89 to -31.11
|
-33.53 score on a scale
Interval -41.59 to -25.48
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who completed 6-minute walk test at both baseline and 24 week visit
Difference in change in 6-minute walk test distance measured in meters, assessed at baseline and week-24 by study arm. The 6-minute walk test measures the number of meters walked over six minutes with a higher score indicating a larger number of meters walked and a lower score indicating a smaller number of meters walked with a minimum score of 0 and a maximum score of 999. The change in 6-minute walk is calculated by subtracting the baseline walk score from the 24-week score. A higher number indicates a greater change from baseline.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=50 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=50 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in 6-minute Walk Test Distance From Baseline to TB Treatment Completion
|
48.69 Meters
Standard Error 11.42
|
11.88 Meters
Standard Error 11.52
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who had a 6 minute timed walk test measure and oxygen saturation measurement at both baseline and 24 weeks.
Difference in change in 6-minute walk test distance-saturation product measured in meters times percent oxygen saturation, assessed at baseline and at week-24 by study arm. The 6-minute walk test distance saturation product measures the number of meters a patient walks over six minutes multiplied by the oxygen saturation at completion of the walk with a higher score indicating better outcome with a minimum score of 0 and a maximum score or 999. The change in 6-minute walk saturation product is calculated by subtracting the baseline score from the 24-week score. A higher number indicates a greater change from baseline.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=48 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=47 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in 6-minute Walk Test Distance-saturation Product From Baseline to TB Treatment Completion
|
51.66 Meters * %SpO2
Interval 28.77 to 74.54
|
7.68 Meters * %SpO2
Interval -14.97 to 30.33
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who had FVC measurement at both baseline and 24 weeks
Difference in change in Forced Vital Capacity (liters) measured at baseline and week-24 by study arm. The maximum FVC is 15 liters and the minimum is 0 liters. The difference from baseline to 24 weeks is calculated by subtracting the baseline FVC from the 24 week FVC. A higher number indicates a greater change from baseline.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=49 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=50 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in FVC From Baseline to TB Treatment Completion
|
-0.00 Liters
Interval -0.09 to 0.09
|
0.10 Liters
Interval 0.01 to 0.19
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who had a FEV1 (% Predicted) at both baseline and 24 weeks
Difference between Forced Expiratory Volume in 1 second (% predicted) measured at baseline and week-24 by study arm. The maximum FEV1% is 150 and the minimum is 0. The difference from baseline to 24 weeks is calculated by subtracting the baseline FEV1% from the 24 week FEV1%. A higher number indicates a greater change from baseline.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=48 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=50 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in FEV1% From Baseline to TB Treatment Completion
|
1.89 percent predicted FEV1
Interval 0.0 to 3.79
|
1.21 percent predicted FEV1
Interval -0.65 to 3.08
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Participants who completed the St. George's Respiratory Questionnaire at both baseline and 24 weeks
Difference in change in St. George's Respiratory Questionnaire score at baseline and week-24 by study arm. The St. George's Respiratory Questionnaire measures health impairment in patients with respirator disease. The potential scores range from 0 to 100 with higher scores indicating more severe impairment. The change in score from baseline to 24 weeks is analyzed by subtracting the baseline score from the 24 week score. High negative magnitude of change indicates greater improvement.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=49 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=50 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Change in St. George's Respiratory Questionnaire Score From Baseline to TB Treatment Completion
|
-25.56 units on a scale
Interval -29.32 to -21.79
|
-23.32 units on a scale
Interval -27.06 to -19.59
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: All participants
The cumulative number of participants in each arm experiencing adverse events of any grade, assessed on every visit from week-1 to week-24.
Outcome measures
| Measure |
Standard Tuberculosis Medicines
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=56 Participants
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Number of Participants Experiencing One or More Adverse Event of Any Grade
|
45 Participants
|
44 Participants
|
Adverse Events
Standard Tuberculosis Medicines
Serious events: 4 serious events
Other events: 43 other events
Deaths: 1 deaths
Standard Tuberculosis Medicines and Metformin
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Tuberculosis Medicines
n=56 participants at risk
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=56 participants at risk
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary disorders
Hepatic Failure
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Investigations
TB Treatment Failure
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • Number of events 1 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
Other adverse events
| Measure |
Standard Tuberculosis Medicines
n=56 participants at risk
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months.
|
Standard Tuberculosis Medicines and Metformin
n=56 participants at risk
Participants are randomized to receive standard tuberculosis medicines (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) in a combination pill pack taken by mouth daily for 2 months. This is followed by Isoniazid and Rifampicin for 4 months. They also take Metformin hydrochloride, one 500 mg tablet, daily starting one week after the initiation of tuberculosis medicines, increasing to one 500 mg tablet twice daily through study week-12 for a total of 11 weeks of metformin exposure.
|
|---|---|---|
|
Blood and Lymphatic System Disorders
ANEMIA
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Blood and Lymphatic System Disorders
LYMPHADENOPATHY
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Cardiac Disorders
CHEST PAIN
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Cardiac Disorders
HYPERTENSION
|
19.6%
11/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Cardiac Disorders
HYPOTENSION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Cardiac Disorders
PALPITATIONS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Ear and Labyrinth Disorders
EAR PAIN
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Ear and Labyrinth Disorders
HEARING IMPAIRED
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Eye Disorders
DRY EYE
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Eye Disorders
EYE PAIN
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
ABDOMINAL PAIN
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
ANAL FISSURE
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
ANGULAR STOMATITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
ANOREXIA
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
CONSTIPATION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
DIARRHEA
|
8.9%
5/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
8.9%
5/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
DYSGEUSIA
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
DYSPEPSIA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
7.1%
4/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
GASTRITIS
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
10.7%
6/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
GASTROENTERITIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
HAEMORRHOIDS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
HEMATEMESIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
MUCOSITIS ORAL
|
7.1%
4/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
NAUSEA
|
7.1%
4/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
14.3%
8/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
OTHER, GI INTOLERANCE
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Gastrointestinal Disorders
VOMITING
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
32.1%
18/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary Disorders
CONGESTIVE HEPATOPATHY
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Hepatobiliary disorders
HEPATITIS
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Immune System Disorders
ALLERGIC REACTION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Immune System Disorders
TB-IRIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
BACTERIAL VAGINOSIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
CANDIDIASIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
CONJUNCTIVITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
FOLLICULITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
NAIL INFECTION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
ORAL CANDIDIASIS
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
PHARYNGITIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
PNEUMONIA
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
SCABIES
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
SHINGLES
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
SKIN INFECTION
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
TONSILLITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
UPPER RESPIRATORY INFECTION
|
14.3%
8/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
19.6%
11/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
URETHRAL INFECTION
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
URINARY TRACT INFECTION
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Infections and Infestations
VAGINAL INFECTION
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Investigations
LACTATE ELEVATION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Investigations
WEIGHT LOSS
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Metabolism and Nutrition Disorders
DEHYDRATION
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Metabolism and Nutrition Disorders
HYPERGLYCAEMIA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Metabolism and Nutrition Disorders
HYPERKALEMIA
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
ARTHRALGIA
|
12.5%
7/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
10.7%
6/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
BACK PAIN
|
7.1%
4/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
CHEST WALL PAIN
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
MUSCLE CRAMP
|
5.4%
3/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
MYALGIA
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
7.1%
4/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Musculoskeletal and Connective Tissue Disorders
PAIN IN EXTREMITY
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Nervous System Disorders
HEADACHE
|
8.9%
5/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
16.1%
9/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Nervous System Disorders
NEURALGIA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Nervous System Disorders
PERIPHERAL SENSORY NEUROPATHY
|
16.1%
9/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
16.1%
9/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Nervous System Disorders
SOMNOLENCE
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Nervous system disorders
DIZZINESS
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Psychiatric Disorders
ANXIETY
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Psychiatric Disorders
HALLUCINATIONS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Renal and Urinary Disorders
ACUTE KIDNEY INJURY
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Reproductive System and Breast Disorders
MENORRHAGIA
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Reproductive System and Breast Disorders
VAGINAL DRYNESS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
COUGH
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
EPISTAXIS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
HEMOPTYSIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
HYPOXIA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
PLEURITIC PAIN
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
10.7%
6/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
PRODUCTIVE COUGH
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Respiratory, Thoracic and Mediastinal Disorders
RHINITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
ANGIOEDEMA
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
DRY SKIN
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
ECZEMATOUS DERMATITIS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
GENITAL ULCER
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
PRURITIS
|
10.7%
6/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
14.3%
8/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
RASH ACNEIFORM
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
RASH MACULOPAPULAR
|
12.5%
7/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
12.5%
7/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
Skin and Subcutaneous Tissue Disorders
SKIN HYPERPIGMENTATION
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
3.6%
2/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
General Disorders
BODY PAIN
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
General Disorders
FLU-LIKE SYMPTOMS
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
General Disorders
NIGHT SWEATS
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
|
General Disorders
NON-CARDIAC CHEST PAIN
|
1.8%
1/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
0.00%
0/56 • 36 weeks
All adverse events (AE) will be captured on the Adverse Event CRF (AE001). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed by a METHOD trial study clinician), and time of resolution/stabilization of the event. All AEs occurring while on study drug are documented appropriately regardless of relationship. All AEs will be followed to stability.
|
Additional Information
Dr. Hardy Kornfeld
University of Massachusetts Chan Medical School
Phone: (508) 856-2646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place