Trial Outcomes & Findings for VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus (NCT NCT01528254)
NCT ID: NCT01528254
Last Updated: 2020-09-24
Results Overview
Treatment failure was defined as two consecutive scheduled visits with HbA1c \>= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2004 participants
Primary outcome timeframe
Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Results posted on
2020-09-24
Participant Flow
It was planned to screen approximately 4000 patients in order to randomize 2000 patients. Actually, 2001 patients were randomized, 998 patients into the Vilda 50mg bid + metformin group and 1003 into the placebo + metformin group.
Participant milestones
| Measure |
Vilda 50mg Bid + Metformin
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Overall Study
STARTED
|
998
|
1003
|
|
Overall Study
Safety Set
|
998
|
1001
|
|
Overall Study
Full Analysis Set (FAS)
|
983
|
989
|
|
Overall Study
Completed Treatment Period 1
|
458
|
273
|
|
Overall Study
Completed Treatment Period 2
|
244
|
399
|
|
Overall Study
Completed Treatment Period 3
|
109
|
115
|
|
Overall Study
COMPLETED
|
811
|
787
|
|
Overall Study
NOT COMPLETED
|
187
|
216
|
Reasons for withdrawal
| Measure |
Vilda 50mg Bid + Metformin
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Overall Study
Administrative problems
|
96
|
94
|
|
Overall Study
Adverse Event
|
28
|
44
|
|
Overall Study
Lost to Follow-up
|
17
|
24
|
|
Overall Study
Death
|
13
|
9
|
|
Overall Study
Protocol deviation
|
9
|
19
|
|
Overall Study
New therapy for study indication
|
8
|
6
|
|
Overall Study
Unsatisfactory therapeutic effect
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Abnormal laboratory value(s)
|
3
|
7
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
0
|
|
Overall Study
No longer requires study drug
|
1
|
1
|
Baseline Characteristics
Only patients with at least one measurement on or prior to Day 1 are included.
Baseline characteristics by cohort
| Measure |
Vilda 50mg Bid + Metformin
n=998 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=1003 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
Total
n=2001 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 9.54 • n=998 Participants
|
54.6 Years
STANDARD_DEVIATION 9.24 • n=1003 Participants
|
54.3 Years
STANDARD_DEVIATION 9.39 • n=2001 Participants
|
|
Sex: Female, Male
Female
|
545 Participants
n=998 Participants
|
515 Participants
n=1003 Participants
|
1060 Participants
n=2001 Participants
|
|
Sex: Female, Male
Male
|
453 Participants
n=998 Participants
|
488 Participants
n=1003 Participants
|
941 Participants
n=2001 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
605 Participants
n=998 Participants
|
612 Participants
n=1003 Participants
|
1217 Participants
n=2001 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 Participants
n=998 Participants
|
23 Participants
n=1003 Participants
|
49 Participants
n=2001 Participants
|
|
Race/Ethnicity, Customized
Asian
|
186 Participants
n=998 Participants
|
187 Participants
n=1003 Participants
|
373 Participants
n=2001 Participants
|
|
Race/Ethnicity, Customized
Native American
|
103 Participants
n=998 Participants
|
107 Participants
n=1003 Participants
|
210 Participants
n=2001 Participants
|
|
Race/Ethnicity, Customized
Other
|
78 Participants
n=998 Participants
|
74 Participants
n=1003 Participants
|
152 Participants
n=2001 Participants
|
|
glycosylated hemoglobin (HbA1c)
|
6.7 Percent
STANDARD_DEVIATION 0.45 • n=996 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
6.7 Percent
STANDARD_DEVIATION 0.47 • n=1003 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
6.7 Percent
STANDARD_DEVIATION 0.46 • n=1999 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
|
fasting plasma glucose (FPG)
|
7.1 mmol/l
STANDARD_DEVIATION 1.40 • n=996 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
7.2 mmol/l
STANDARD_DEVIATION 1.47 • n=1003 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
7.1 mmol/l
STANDARD_DEVIATION 1.44 • n=1999 Participants • Only patients with at least one measurement on or prior to Day 1 are included.
|
|
Duration of type 2 diabetes
|
6.2 months
STANDARD_DEVIATION 7.00 • n=998 Participants
|
6.6 months
STANDARD_DEVIATION 8.05 • n=1003 Participants
|
6.4 months
STANDARD_DEVIATION 7.55 • n=2001 Participants
|
|
Glomerular Filtration Rate (Modification of Diet in Renal Disease)
Normal (>80)
|
660 Participants
n=998 Participants
|
661 Participants
n=1003 Participants
|
1321 Participants
n=2001 Participants
|
|
Glomerular Filtration Rate (Modification of Diet in Renal Disease)
Mild (>=50 - <=80)
|
333 Participants
n=998 Participants
|
337 Participants
n=1003 Participants
|
670 Participants
n=2001 Participants
|
|
Glomerular Filtration Rate (Modification of Diet in Renal Disease)
Moderate (>=30 - <50)
|
3 Participants
n=998 Participants
|
4 Participants
n=1003 Participants
|
7 Participants
n=2001 Participants
|
|
Glomerular Filtration Rate (Modification of Diet in Renal Disease)
Severe (<30)
|
0 Participants
n=998 Participants
|
1 Participants
n=1003 Participants
|
1 Participants
n=2001 Participants
|
|
Glomerular Filtration Rate (Modification of Diet in Renal Disease)
Missing
|
2 Participants
n=998 Participants
|
0 Participants
n=1003 Participants
|
2 Participants
n=2001 Participants
|
|
Is subject a current smoker?
Is subject a current smoker?=Yes
|
154 Participants
n=998 Participants
|
136 Participants
n=1003 Participants
|
290 Participants
n=2001 Participants
|
|
Is subject a current smoker?
Is subject a current smoker?=No
|
844 Participants
n=998 Participants
|
867 Participants
n=1003 Participants
|
1711 Participants
n=2001 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)Population: Full Analysis Set (FAS)
Treatment failure was defined as two consecutive scheduled visits with HbA1c \>= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=983 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=989 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Time to Initial Treatment Failure
Year 2
|
17.79 Rate (%)
Interval 15.49 to 20.38
|
34.67 Rate (%)
Interval 31.72 to 37.82
|
|
Time to Initial Treatment Failure
Year 4
|
39.84 Rate (%)
Interval 36.74 to 43.11
|
59.29 Rate (%)
Interval 56.08 to 62.53
|
|
Time to Initial Treatment Failure
Weeks 13-52
|
7.81 Rate (%)
Interval 6.28 to 9.7
|
19.97 Rate (%)
Interval 17.58 to 22.65
|
|
Time to Initial Treatment Failure
Year 3
|
31.24 Rate (%)
Interval 28.35 to 34.33
|
48.31 Rate (%)
Interval 45.12 to 51.61
|
|
Time to Initial Treatment Failure
Year 5
|
46.41 Rate (%)
Interval 43.2 to 49.74
|
66.57 Rate (%)
Interval 63.43 to 69.69
|
|
Time to Initial Treatment Failure
> Year 5
|
52.67 Rate (%)
Interval 44.29 to 61.58
|
74.39 Rate (%)
Interval 68.39 to 80.04
|
SECONDARY outcome
Timeframe: Visit 5 (Week 26) to End of Period 1Population: Full Analysis Set (FAS)
The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=983 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=989 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Loss in Glycemic Control During Period 1
|
0.24 Rate (%)
Standard Error 0.01
|
0.27 Rate (%)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: From 26 weeks after start of Period 2 to end of Period 2Population: Full Analysis Set (FAS)
The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from 26 weeks after the start of Period 2 to the end of Period 2 were included in the analysis, for participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=410 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=588 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2
|
1.11 Rate (%)
Standard Error 0.15
|
1.02 Rate (%)
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Visit 5 (Week 26) to End of Period 1Population: Full Analysis Set (FAS)
Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from Week 26 to the end of Period 1 was included in the analysis. Baseline FPG was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement is missing. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=983 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=989 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1
|
0.25 Rate (%)
Standard Error 0.01
|
0.26 Rate (%)
Standard Error 0.01
|
SECONDARY outcome
Timeframe: From 26 weeks after start of Period 2 to end of Period 2Population: Full Analysis Set (FAS)
Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from 26 weeks after the start of Period 2 to then end of Period 2 was included in the analysis. Only participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3 were included. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=410 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=588 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2
|
1.27 Rate (%)
Standard Error 0.25
|
0.99 Rate (%)
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)Population: Full Analysis Set (FAS) meal-test subset
The rate of change of beta cell function was assessed using the slope of AUC of ISR/G over time (years) where AUC of ISR/G is defined as (Area under curve of Insulin secretion rate (derived using c-peptide))/(Area under curve of Glucose), using meal-test data from 0 to 120 minutes. Baseline AUC of ISR/G was derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements were missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=228 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=227 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Loss of Beta Cell Function From Baseline to End of Study
From Week 13 to end of Period 1
|
-0.60 Rate (%)
Standard Error 0.15
|
-0.53 Rate (%)
Standard Error 0.18
|
|
Rate of Loss of Beta Cell Function From Baseline to End of Study
From Week 13 to end of Period 2
|
-0.93 Rate (%)
Standard Error 0.14
|
-0.43 Rate (%)
Standard Error 0.15
|
|
Rate of Loss of Beta Cell Function From Baseline to End of Study
From Week 13 to end of study
|
-1.04 Rate (%)
Standard Error 0.15
|
-0.46 Rate (%)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)Population: Full Analysis Set (FAS) meal-test subset
The rate of change of insulin sensitivity is assessed using the slope of OGIS over time (years) where Oral glucose insulin sensitivity (OGIS) was calculated as a function of glucose and insulin, using meal-test data from 0 to 120 minutes. Baseline OGIS is derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements are missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=228 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=227 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Rate of Change in Insulin Sensitivity From Baseline to End of Study
From Week 13 to end of Period 1
|
-4.61 Rate (%)
Standard Error 1.38
|
0.41 Rate (%)
Standard Error 1.66
|
|
Rate of Change in Insulin Sensitivity From Baseline to End of Study
From Week 13 to end of Period 2
|
-6.07 Rate (%)
Standard Error 1.20
|
-0.99 Rate (%)
Standard Error 1.24
|
|
Rate of Change in Insulin Sensitivity From Baseline to End of Study
From Week 13 to end of study
|
-6.39 Rate (%)
Standard Error 1.15
|
-1.01 Rate (%)
Standard Error 1.17
|
SECONDARY outcome
Timeframe: From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)Population: Safety Set (SAF). Percentages are based on the number of patients starting each period.
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that LAF237 is safe for the treatment of naïve patients with type 2 diabetes mellitus through the monitoring of relevant clinical and laboratory safety parameters.
Outcome measures
| Measure |
Vilda 50mg Bid + Metformin
n=998 Participants
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=1001 Participants
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
|---|---|---|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Death
On-treatment Adverse Event (AEs)
|
83.5 Percentage of Participants
|
83.2 Percentage of Participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Death
On-treatment Serious Adverse Event (SAEs)
|
16.6 Percentage of Participants
|
18.3 Percentage of Participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Death
On-treatment Deaths
|
1.3 Percentage of Participants
|
0.9 Percentage of Participants
|
Adverse Events
Vilda 50mg Bid + Metformin
Serious events: 166 serious events
Other events: 582 other events
Deaths: 13 deaths
Placebo + Metformin
Serious events: 183 serious events
Other events: 566 other events
Deaths: 9 deaths
Total
Serious events: 349 serious events
Other events: 1148 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Vilda 50mg Bid + Metformin
n=998 participants at risk
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=1001 participants at risk
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
Total
n=1999 participants at risk
Total
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Angina pectoris
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
6/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Angina unstable
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
6/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
5/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.55%
11/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiac failure
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiac failure acute
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.70%
7/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
10/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Congenital, familial and genetic disorders
Congenital intestinal malformation
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Endocrine disorders
Goitre
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Endocrine disorders
Hypoparathyroidism
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Eye disorders
Diplopia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Eye disorders
Vitreous haemorrhage
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Anal fissure
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Food poisoning
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastrointestinal erosion
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.70%
7/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Chest pain
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Death
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Granuloma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Inflammation
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Non-cardiac chest pain
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Oedema peripheral
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Peripheral swelling
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Pyrexia
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Stent-graft endoleak
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
General disorders
Sudden death
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
4/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
6/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
5/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Immune system disorders
Anaphylactic reaction
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Anal abscess
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Appendicitis
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Bartholin's abscess
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Bone tuberculosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Bronchitis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Cervicitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Dengue fever
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Epididymitis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Hepatic echinococciasis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Hepatitis viral
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Infection
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Lung infection
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Mastoiditis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Meningitis pneumococcal
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Pneumonia
|
1.4%
14/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
5/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.95%
19/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Pyelonephritis acute
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Pyelonephritis chronic
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Rectal abscess
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Sepsis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Urinary tract infection
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Viral infection
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Viral myelitis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
Aspartate aminotransferase increased
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
HIV test positive
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Investigations
Transaminases increased
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
5/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystadenocarcinoma ovary
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder neoplasm
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant splenic neoplasm
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligoastrocytoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.60%
6/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
6/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with multilineage dysplasia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated sarcoma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Coma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Demyelination
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Headache
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Hemiparesis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.50%
5/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.35%
7/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Radiculopathy
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Sciatica
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
4/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Seizure
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Syncope
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with contraceptive device
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Psychiatric disorders
Depression
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Bladder tamponade
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Calculus bladder
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Haematuria
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
3/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Renal colic
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Stag horn calculus
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Ovarian fibrosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
3/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.25%
5/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Aortic aneurysm
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Aortic dissection
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Aortic stenosis
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Haematoma
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Hypertension
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.40%
4/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.30%
6/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.20%
2/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
2/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Peripheral venous disease
|
0.10%
1/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.00%
0/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.05%
1/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Varicose vein
|
0.20%
2/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.10%
1/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
0.15%
3/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
Other adverse events
| Measure |
Vilda 50mg Bid + Metformin
n=998 participants at risk
vildagliptin (Vilda 50mg bid) + Metformin
|
Placebo + Metformin
n=1001 participants at risk
Placebo of vildagliptin (Vilda 50mg bid) + Metformin
|
Total
n=1999 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
104/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
10.4%
104/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
10.4%
208/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Bronchitis
|
5.8%
58/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
5.9%
59/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
5.9%
117/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Influenza
|
9.3%
93/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
6.4%
64/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.9%
157/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
104/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
10.8%
108/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
10.6%
212/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
83/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
6.9%
69/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.6%
152/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Infections and infestations
Urinary tract infection
|
7.2%
72/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
6.9%
69/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.1%
141/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.8%
58/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.1%
71/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
6.5%
129/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
100/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
9.4%
94/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
9.7%
194/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
105/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
8.6%
86/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
9.6%
191/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.4%
54/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
4.0%
40/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
4.7%
94/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
67/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.4%
74/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.1%
141/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Dizziness
|
6.7%
67/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
4.1%
41/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
5.4%
108/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Nervous system disorders
Headache
|
8.2%
82/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.2%
72/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
7.7%
154/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
|
Vascular disorders
Hypertension
|
10.3%
103/998 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
12.4%
124/1001 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
11.4%
227/1999 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 75.6 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Maximum exposure to study treatments = 75.6 months (Vilda 50mg bid + metformin arm) and 66.2 months (Placebo + metformin arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER