Trial Outcomes & Findings for OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (NCT NCT01182493)

NCT ID: NCT01182493

Last Updated: 2018-03-12

Results Overview

To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 331 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2018-03-12

Participant Flow

36 hospitals, tertiary care centres, and referal centres participated: eight in Canada, 23 in Europe and Israel, two in South Africa, and three in the USA. The study started in December 2010, and the fi nal data collection date for the primary outcome measure was in February 2014

Participant milestones

Measure	Insulin Pump Treatment Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Overall Study STARTED	168	163
Overall Study COMPLETED	152	156
Overall Study NOT COMPLETED	16	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy

Baseline characteristics by cohort

Measure	Insulin Pump Treatment n=168 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient	Insulin Treatment With MDI n=163 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day	Total n=331 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	168 Participants n=5 Participants	163 Participants n=7 Participants	331 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55.5 years STANDARD_DEVIATION 9.7 • n=5 Participants	56.4 years STANDARD_DEVIATION 9.5 • n=7 Participants	56.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	77 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	86 Participants n=7 Participants	180 Participants n=5 Participants
HbA1c	9.0 % of glycosylated hemoglobin STANDARD_DEVIATION 0.75 • n=5 Participants	9.0 % of glycosylated hemoglobin STANDARD_DEVIATION 0.76 • n=7 Participants	9.0 % of glycosylated hemoglobin STANDARD_DEVIATION 0.75 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline

Outcome measures

Measure	Insulin Pump Treatment n=168 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=163 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Between Group Difference in HbA1c When Comparing CSII to MDI	-1.1 Change in % HbA1c Standard Deviation 1.2	-0.4 Change in % HbA1c Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 months

Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline

Outcome measures

Measure	Insulin Pump Treatment n=113 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=108 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)	0 mg/dL/min Standard Deviation 0.6	-0.1 mg/dL/min Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 months

Severe hypoglycemia incidence during the study

Outcome measures

Measure	Insulin Pump Treatment n=168 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=163 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Safety - Severe Hypoglycemia Incidence	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline

Outcome measures

Measure	Insulin Pump Treatment n=113 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=108 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)	-11 mg/dL/min Standard Deviation 26.3	-2.6 mg/dL/min Standard Deviation 17.4

SECONDARY outcome

Timeframe: 6 months

Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores

Outcome measures

Measure	Insulin Pump Treatment n=140 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=143 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)	4.75 score Standard Deviation 6.9	-0.26 score Standard Deviation 6.9

SECONDARY outcome

Timeframe: 6 months

Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight

Outcome measures

Measure	Insulin Pump Treatment n=151 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=154 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Change in Body Weight	1.52 kg Standard Deviation 3.53	1.12 kg Standard Deviation 3.62

SECONDARY outcome

Timeframe: 6 Months

Diabetic Ketoacidosis incidence during the study

Outcome measures

Measure	Insulin Pump Treatment n=168 Participants Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=163 Participants patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Safety - Diabetic Ketoacidosis Incidence	0 Participants	0 Participants

Adverse Events

Insulin Pump Treatment

Serious events: 13 serious events

Other events: 108 other events

Deaths: 0 deaths

Insulin Treatment With MDI

Serious events: 10 serious events

Other events: 99 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Pump Treatment n=168 participants at risk Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=163 participants at risk patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Infections and infestations Cellulitis on left lower abdomen	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Vascular disorders Exacerbation of Hypertension	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Eye disorders Retinal Hemorrhage Right Eye	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders acute coronary syndrome	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations abscess	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders chronic hyperglycemia	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders tachycardia	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders CARDIAC ARYTHMIA WITH ATRIAL FIBRILLATION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders chest pain	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Surgical and medical procedures coronary artery bypass graft	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations PNEUMONIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders acute pancreatitis	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders postmenopausal bleeding with abnormality of cervix, hyperplasia	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders Congestive Heart Failure	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders Knee arthrosis	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders Ketosis	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders Spinal stenosis L1-L2	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations Hepatic abscess	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations Worsening Hepatic Abscess	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders Pancreatitis	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders heart Failure	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders abdominal pain	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders hyperglycemia with ketosis without acidosis	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders Hepatic Encephalophthy	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders Atypical Ductal Hyperplasia	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders Chest Pain (non cardiac)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)

Other adverse events

Measure	Insulin Pump Treatment n=168 participants at risk Patients will get an insulin pump Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.	Insulin Treatment With MDI n=163 participants at risk patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA - RIGHT EAR	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LESION(LIPOMA) OF SKIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Blood and lymphatic system disorders ANEMIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Blood and lymphatic system disorders SWOLLEN LYMPH NODES	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders ATRIAL FIBRILLATION REOCCURENCE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders CARDIAC INSUFFICIENCY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders CONGESTIVE HEART FAILURE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Cardiac disorders HEART BEATING PALPITATIONS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders ISCHEMIC CARDIOMYOPATHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders MIOCARDIAL INFARCTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders MITRAL INSUFFICIENCY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders PALPITATIONS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Cardiac disorders SINUSTACHYCARDIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Ear and labyrinth disorders BLOCKED RIGHT EAR	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Ear and labyrinth disorders HEARING LOSS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Ear and labyrinth disorders PERICHONDRITIS OF HUMEROSCAPULAR JOINT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Endocrine disorders HYPOTHYROIDISM	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Endocrine disorders MULTINODULAR GOITER	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders BEGINNING MACULOPATHY OF THE LEFT EYE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders BILATERAL GLAUCOMA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Eye disorders EARLY CATARACTS-BOTH EYES	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders IRRITATION LEFT EYE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders LEFT EYE MACULAR EDEMA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Eye disorders MINIMAL DIABETIC RETINOPATHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders PROLIFERATIVE RETINOPATHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Eye disorders WORSENED GLAUCOMA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Eye disorders WORSENING OF DEGENERATIVE MACULOPATHY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders ABDOMINAL BLOATING	1.2% 2/168 • Number of events 3 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders ABDOMINAL PAIN	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders BLACK STOOL	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders COLON POLYPS	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders DIARRHEA	2.4% 4/168 • Number of events 4 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders DIARRHEA (DUE TO METFORMIN)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders DIGESTIVE DISORDERS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders ENTEROCOLLITIS ACUTA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders FLATULENCE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders GASTRO-INTESTINAL SIDE EFFECTS OF METFORMIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders GI REFLUX	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders INDIGESTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders INTERMITTENT DIARRHEA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders INTERMITTENT NAUSEA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders LESIONS ON TONGUE, LIP, AND THROAT.	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders MULTIPLE SMALL STOMACH ULCERS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders NAUSEA	1.8% 3/168 • Number of events 3 • All adverse events reported during the study period (6 months)	2.5% 4/163 • Number of events 4 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders RECTAL BLEEDING	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders STOMACH CRAMPS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders TEETH PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders TOOTH PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders VOMITING	1.8% 3/168 • Number of events 3 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders VOMITING EPISODE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Gastrointestinal disorders VOMITTING	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders ABDOMINAL BRUISING FROM SENSOR INSERTION SITE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders ANASARCA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders ATYPICAL CHEST PAIN	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders BLEEDING	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders BLEEDING FOLLOWING SENSOR INSERTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders BLEEDING FROM INFUSION SITE	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders BLEEDING FROM INFUSION SITE UPON REMOVAL	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders CHEST PAIN	1.8% 3/168 • Number of events 3 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 3 • All adverse events reported during the study period (6 months)
General disorders EDEMA - BILATERAL LEGS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders EDEMA IN BOTH LEGS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders FATIGUE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders FEET SWELLING	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders FEVER	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders FLU LIKE SYMPTOMS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders FLU LIKE SYMPTOMS AFTER RECEIVING FLU VACCINATION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders HERNIA	0.60% 1/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders INCREASE OF SWELLING IN BOTH FEET	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders INFLAMMATION LEFT GROIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders INFLAMMATORY NODULE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders INFUSION SITE PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders INTOLERANCE TO METFORMIN	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 2 • All adverse events reported during the study period (6 months)
General disorders PERIPHERAL EDEMA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders RASH AT SITE OF INFUSION INSERTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders REDNESS AROUND IPRO INSERTION SITE.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders SOLITARY BENIGN CYST	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders SWELLING IN FEET, BILATERAL	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
General disorders SWELLING OF BOTH FEET	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
General disorders THORACIC PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Hepatobiliary disorders ENLARGED LIVER	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Hepatobiliary disorders HEPATIC CIRROSIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Immune system disorders ALLERGIC RESPONSE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ABDOMINAL WALL ABSCESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ABSCESS - NECK	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ABSCESS RIGHT BUTTOCKS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ACUTE BRONCHITIS	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Infections and infestations ACUTE CYSTITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ACUTE GASTRO-ENTERITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations ACUTE TONSILLITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations BLADDER INFECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations BRONCHITIS	2.4% 4/168 • Number of events 5 • All adverse events reported during the study period (6 months)	5.5% 9/163 • Number of events 11 • All adverse events reported during the study period (6 months)
Infections and infestations BRONCHITIS ACUTE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS	1.2% 2/168 • Number of events 3 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS - RIGHT FOOT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS ON LEFT ABDOMEN	0.60% 1/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS ON RIGHT ABDOMEN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS ON RIGHT LOWER ABDOMEN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CELLULITIS TO BOTH LEGS.	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CERATOCONJUNCTIVITIS EPIDEMIC	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations CHEST INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations CHRONIC BRONCHITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations COLD	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 4 • All adverse events reported during the study period (6 months)
Infections and infestations COMMON COLD	4.2% 7/168 • Number of events 8 • All adverse events reported during the study period (6 months)	2.5% 4/163 • Number of events 4 • All adverse events reported during the study period (6 months)
Infections and infestations CONDYLOMA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations DENTAL ABSCESS	0.00% 0/168 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Infections and infestations DIVERTICULITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations EAR INFECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ERYSIPELAS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations FLU	1.8% 3/168 • Number of events 3 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Infections and infestations FLU-LIKE SYNDROME	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations FOLLICITIS (INFLAMED HAIR FOLLICLES)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations FOLLICULITIS	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations FUNGAL RASH - BILATERAL BREASTS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations GASTRO ENTERITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations GASTROENTERITIS	1.2% 2/168 • Number of events 3 • All adverse events reported during the study period (6 months)	3.7% 6/163 • Number of events 6 • All adverse events reported during the study period (6 months)
Infections and infestations H. PYLORI INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations HERPES SIMPLEX	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations INFECTED TOE ON LEFT FOOT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations INFECTION IN LEFT HIP	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations INFECTION OF UPPER LIP	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations INFECTION ON RIGHT LOWER LEG	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations INTERMITTEND URINARY TRACT INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations INTESTINAL INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations KIDNEY INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations LEFT EAR INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations LOCAL INFECTION AROUND PUMP CATETER INSERTION SITE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations LOCAL SKIN INFECTION AT NEEDLE SITE INJECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations MIDDLE EAR INFECTION (OTITIS MEDIA) LEFT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations NASOPHARYNGITIS	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ONYCHOMYCOSIS RIGHT BIG TOE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations ONYCHOMYCOSIS.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations OTITIS MEDIA LATERALIS DEXTRI	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations PENILE INFECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations PHARYNGITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations PHARYNGITIS.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations PNEUMONIA	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Infections and infestations PROBABLE VIRAL GASTROENTERITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations RECURRENT SKIN INFECTIONS AFTER REMOVAL OF INFUSION SET	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations RECURRENT SKIN INFECTIONS(INFUSION SITE)EXACERBATION OF AE-4	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations RESPIRATORY INFECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations SCROTAL ABSCESS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations SHINGLES	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations SINUS COLD	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Infections and infestations SINUS INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Infections and infestations SINUSITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	2.5% 4/163 • Number of events 4 • All adverse events reported during the study period (6 months)
Infections and infestations SKIN ABSCESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations SUBCUTANOUSE ABCESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations SUPERFICIAL SKIN INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations TONSILITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations TONSILLITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations TOOTH ABSCESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations TOOTH DECAY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations TOOTH INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations UPPER RESPIRATORY INFECTION	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.4% 9/168 • Number of events 11 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Infections and infestations URINARY INFECTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Infections and infestations URINARY TRACT INFECTION	3.6% 6/168 • Number of events 6 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Infections and infestations VAGINAL CANDIDIASIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations WORSENING SKIN ABSCESS, UNDERARM, BILATERALLY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Infections and infestations YEAST INFECTION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications ANKLE SPRAIN-RIGHT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications ANTERIOR WEDGE COMPRESION FRACTURE OF T12 VERTEBRA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications BRUISED LEFT KNEE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications BURN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications BURN OF TOES OF FEET	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications CONTUSION TO BUTTOCK	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications CONTUSIONS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications CONTUSIONS TO LEFT ELBOW	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications DRY BRUISING	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications FALL	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications FALL - ABRASIONS TO BOTH KNEES	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications FRACTURE OF FIFTH METATHARSAL BONE RIGHT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications FRACTURED RIGHT MALLEOLUS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications HEAD TRAUMA RIGHT TEMPORAL REGION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications HEAT STROKE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications INJURY RIGHT LOWER LEG	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications LEFT 2ND DIGIT INDEX FINGER PROXIMAL PHALANX SKIN REMOVED	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications LEFT MENISCUS TEAR	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications LEFT THUMB DISLOCATION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications POISON IVY (SKIN REACTION)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications POSTERIOR MUSCLE STRAIN BETWEEN SHOULDER BLADES (SCAPULAE).	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications RECCURENCE OF ACHILLES TENDON RUPTURE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications RIGHT LATERAL EPICONDYLITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications RIGHT SHOULDER INJURY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications SECOND DEGREE BURN ON RIGHT FOREFOOT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications SOFT TISSUE INJURY TO NECK AND SHOULDERS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications SPRAINED ANKLE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications SPRAINED LEFT KNEE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Injury, poisoning and procedural complications SUPERFICIAL WOUNDS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Investigations EXCESSIVE WEIGHT GAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Investigations FECAL OCCULT BLOOD TEST POSITIVE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Investigations INCREASE OF GGT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Investigations INCREASED LIVER ENZYMES	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Investigations INCREASED PRESSURE BEHIND THE RIGHT EYE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders DIABETIC FOOT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders DIABETIC FOOT (LT- TOE 5)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders DIABETIC FOOT, LEFT TOE 3.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders DYSLIPIDEMIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders HYPERCALCEMIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders HYPERGLYCEMIA	2.4% 4/168 • Number of events 4 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders HYPERLIPIDEMIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders HYPOMAGNESEMIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders RECURRING HYPERGLICEMIA (481 MG/DL)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders RIGHT FOOT POSSIBLE GOUT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders SEVERE HYPOGLYCEMIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Metabolism and nutrition disorders TYPE 1 FHH (FAMILIAL HYPOCALCIURIC HYPERCALCEMIA)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders ADHESIVE CAPSULITIS (FROZEN SHOULDER) LEFT ARM	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders BACK PAIN	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders BAKERｴS CYST	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders BILATERAL LEG PAIN BELOW KNEES	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders CALCANEAL SPUR	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders CHRONIC LUMBAGO	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders COXITIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders DECREASED RANGE OF MOTION RIGHT ARM	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders DETERIORATION OF RIGHT SHOULDER PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders DIFFUSE MUSCLE AND SKELETAL PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders DORSALGIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders ELBOW PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders EXACERBATION OF BURSITIS RIGHT HIP	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders EXACERBATION OF BURSITIS TO LEFT HIP	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders GENERALIZED MYALGIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders GONARTHROSIS TOGETHER WITH KNEE-JOINT EFFUSION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders HEEL PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders INCREASED NECK PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders INFRAPETELLAR BURSITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders KNEE PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders KNEE STIFFNESS.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LEFT ELBOW PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LEFT HIP PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LEG PAIN (CRAMPING AND SPASMS)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LEGS PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LESION ON RIGHT 1ST METATARSAL	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LOW BACK PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LOWER BACK PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders LUMBAGO	1.2% 2/168 • Number of events 2 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders MUSCLE CRAMPS	0.00% 0/168 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders MUSCLE PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders NECK PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders PAIN IN THE HEEL BONE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders PAIN LEFT ARM -EXACERBATION OF PREEXISTING CONDITION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders PAIN LEFT SHOULDER	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders PAIN WITH HIS SHOULDER	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders POST TRAUMA LEFT HAND PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders PREPATELLAR BURSITIS (RIGHT KNEE)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders RIGHT FLANK PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders RIGHT KNEE ARTHROSIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders RIGHT KNEE PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders RIGHT SHOULDER PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders RIGHT SIDED BACK PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders SEVERE BACK PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders SPINAL COLUMN ARTHROSIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders TENOSYNOVITIS OF THE RIGHT HAND-JOINT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders TORTICOLIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders TRIGGER FINGER	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders VASOVAGAL EPISODE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders WORSENING OF JOINTS PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders WORSENING OF PAIN LEFT LEG	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Musculoskeletal and connective tissue disorders WORSENING RIGHT SHOULDER PAIN	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OSTEOCHONDROMA, RIGHT HALLUX	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLANTARS WART TO LEFT HEEL.	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VERRUCAE VULGARIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders CARPEL TUNNEL SYNDROME	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders CEPHALALGIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders CERVICAL RADICULOPATHY ON C8	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders DIZZINESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Nervous system disorders ELECTIVE SURGERY FOR CARPAL TUNNEL SYNDROME ON LEFT HEND	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders EXACERBATION OF CARPEL TUNNEL SYNDROME	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders EXACERBATION OF PERIFERAL SENSORY NEUROPATHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders HEADACHE	1.8% 3/168 • Number of events 3 • All adverse events reported during the study period (6 months)	1.8% 3/163 • Number of events 3 • All adverse events reported during the study period (6 months)
Nervous system disorders INTERMITTENT DIZZINESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders INTERMITTENT NUMBNESS BOTTOM OF RIGHT FOOT	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders LOWER LIMBS NEUROPATHIC PAIN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders NEUROPATHY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders PARESTHESIA OF HANDS AND TOES	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders PARESTHESIAS IN BOTH FEET	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders POSTURAL DIZZINESS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders RECURRENT HEADACHE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders RECURRENT HEADACHES(INTERMITTENT)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders SCIATIC	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders SCIATICA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders SYNCOPE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Nervous system disorders TREMOR	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Nervous system disorders VAGAL FAINTNESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Psychiatric disorders ANXIETY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Psychiatric disorders DEPRESSION	0.00% 0/168 • All adverse events reported during the study period (6 months)	1.2% 2/163 • Number of events 2 • All adverse events reported during the study period (6 months)
Psychiatric disorders EXACERBATION OF PRE EXISTING CONDITION-DEPRESSION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Psychiatric disorders EXACERBATION OF SYMPTOMS OF DEPRESSION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Psychiatric disorders INSOMNIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Psychiatric disorders STRESS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Psychiatric disorders WORSENING ANXIETY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Psychiatric disorders WORSENING OF DEPRESSION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Renal and urinary disorders BURNING SENSATION WITH MICTURITION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Renal and urinary disorders DIABETIC NEPHROPATHY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Renal and urinary disorders HEMATURIA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Renal and urinary disorders KIDNEY STONES	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Renal and urinary disorders PROTEINURIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Renal and urinary disorders RENAL COLIC	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Renal and urinary disorders RENAL CYST	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Renal and urinary disorders RENAL FUNCTION WORSENING.	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders BALANITIS PREPUTIAL	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders BENIGN HYPERTROPHY OF PROSTATA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders BENIGN PROSTATE HYPERTROPHY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders ENLARGED PROSTATE	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders ERECTILE DYSFONCTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Reproductive system and breast disorders LEFT OVARIAN CYST	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders CHRONIC COUGH	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders NON PRODUCTIVE COUGH	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders PLEURISY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders PLEURITIS (INFLAMMATION OF PLEURA)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders PNEUMOPATHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders RESTRICTIVE LUNG DISEASE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders SORE THROAT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMATION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders 0.5CM SKIN ULCER	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders 2MM SCABBED ROUND LESION	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders ALLERGIC SKIN REACTION TO PLASTER(ADHESIVE OF INFUSION SET)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders BLISTER ON BOTH FIRST METATARSALS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders CONTACT DERMATITIS (BILATERAL HANDS)	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders ECZEMA ON LEFT EAR BACK	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders HIVES	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders INGROWN RIGHT HALLUX TOE NAIL LATERAL BORDER WITH PARONYCHIA	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders INGROWN TOENAIL	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders INGROWN TOENAIL SURGERY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders LIPODYSTROPHY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders LIPOHYPERTROPHY	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders MILD ALLERGIC REACTION TO ADHESIVE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders PERIORBITAL OEDEMA	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders RED RASH ON ABDOMEN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SKIN LESION(BACK)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SKIN ALLERGIC REACTION TO ADHESIVE TAPE (OVERTAPE)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SKIN INFLAMMATION ON ABDOMEN	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SKIN IRRITATION FROM INFUSION SITE ADHESIVE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SKIN LESION RIGHT 1ST PHALANGE PLANTAR ASPECT	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Skin and subcutaneous tissue disorders SUBCUTANEOUS NODULE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Surgical and medical procedures RIGHT ROTATOR CUFF REPAIR (SURGERY)	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Surgical and medical procedures VASECTOMY	0.00% 0/168 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)
Surgical and medical procedures WISDOM TOOTH EXTRACTION LEFT SIDE	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Vascular disorders DEEP VEIN THROMBOSIS - LEFT CALF	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Vascular disorders HOT FLASH	0.60% 1/168 • Number of events 1 • All adverse events reported during the study period (6 months)	0.00% 0/163 • All adverse events reported during the study period (6 months)
Vascular disorders HYPERTENSION	2.4% 4/168 • Number of events 4 • All adverse events reported during the study period (6 months)	0.61% 1/163 • Number of events 1 • All adverse events reported during the study period (6 months)

Additional Information

Prof. Yves Reznik

CHU Caen

Phone: +33231064585

Email: reznik-y@chu-caen.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60