Trial Outcomes & Findings for ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking (NCT NCT00808015)
NCT ID: NCT00808015
Last Updated: 2015-05-12
Results Overview
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Recruitment status
COMPLETED
Target enrollment
1373 participants
Primary outcome timeframe
Week 12
Results posted on
2015-05-12
Participant Flow
A total of 1429 participants were screened for this study and 1377 participants were assigned to the study treatment.
Participant milestones
| Measure |
Varenicline
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Overall Study
STARTED
|
1377
|
|
Overall Study
Treated
|
1373
|
|
Overall Study
COMPLETED
|
1033
|
|
Overall Study
NOT COMPLETED
|
344
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
58
|
|
Overall Study
Lost to Follow-up
|
76
|
|
Overall Study
Participants not willing to participate
|
158
|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Other
|
25
|
|
Overall Study
Enrolled but not treated
|
4
|
Baseline Characteristics
ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
Baseline characteristics by cohort
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Prior Drug Treatment
Omega-3 marine triglycerides
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Omega-3 triglycerides
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Omeprazole
|
3 participants
n=5 Participants
|
|
Medical History
Social phobia
|
2 participants
n=5 Participants
|
|
Medical History
Substance abuse
|
14 participants
n=5 Participants
|
|
Medical History
Bladder irritation
|
1 participants
n=5 Participants
|
|
Medical History
Nephrolithiasis
|
1 participants
n=5 Participants
|
|
Medical History
Proteinuria
|
1 participants
n=5 Participants
|
|
Medical History
Renal failure chronic
|
2 participants
n=5 Participants
|
|
Medical History
Benign prostatic hyperplasia
|
9 participants
n=5 Participants
|
|
Medical History
Erectile dysfunction
|
2 participants
n=5 Participants
|
|
Medical History
Organic erectile dysfunction
|
1 participants
n=5 Participants
|
|
Age, Continuous
|
45.2 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1279 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
88 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
6 Participants
n=5 Participants
|
|
Smoking history: Total number of years participant smoked
|
20.0 Years
n=5 Participants
|
|
Smoking history: Average number of cigarettes smoked per day in the last year
|
20.00 cigarettes
n=5 Participants
|
|
Smoking history: Longest period of abstinence in the last year
|
0.0 Days
n=5 Participants
|
|
Smoking history : Number of times the participant has attempted to quit in past year
|
0.0 Quit attempts
n=5 Participants
|
|
Smoking history : Participant categorized based on number of attempt to quit in the past year
None
|
738 participants
n=5 Participants
|
|
Smoking history : Participant categorized based on number of attempt to quit in the past year
One
|
285 participants
n=5 Participants
|
|
Smoking history : Participant categorized based on number of attempt to quit in the past year
Two
|
107 participants
n=5 Participants
|
|
Smoking history : Participant categorized based on number of attempt to quit in the past year
Three or more
|
127 participants
n=5 Participants
|
|
Smoking history : Did participant live with someone who smoked
Yes
|
247 participants
n=5 Participants
|
|
Smoking history : Did participant live with someone who smoked
No
|
1040 participants
n=5 Participants
|
|
Smoking history : Did participant have frequent contact with someone who smoked
Yes
|
1071 participants
n=5 Participants
|
|
Smoking history : Did participant have frequent contact with someone who smoked
No
|
199 participants
n=5 Participants
|
|
Smoking history: Lifetime serious quit attempts
None
|
16 participants
n=5 Participants
|
|
Smoking history: Lifetime serious quit attempts
One
|
322 participants
n=5 Participants
|
|
Smoking history: Lifetime serious quit attempts
Two
|
117 participants
n=5 Participants
|
|
Smoking history: Lifetime serious quit attempts
Three or more
|
194 participants
n=5 Participants
|
|
Quit History : Main reasons for relapses after previous attempts
Family / Friends
|
164 participants
n=5 Participants
|
|
Quit History : Main reasons for relapses after previous attempts
Smoking is a habitual response to stress/pressure
|
381 participants
n=5 Participants
|
|
Quit History : Main reasons for relapses after previous attempts
Urge to smoke is too strong
|
449 participants
n=5 Participants
|
|
Quit History : Main reasons for relapses after previous attempts
Weight gain
|
20 participants
n=5 Participants
|
|
Quit History : Main reasons for relapses after previous attempts
Exposure to smoke environment
|
227 participants
n=5 Participants
|
|
Quit History : Reasons motivated participant to quit smoking
Health reasons
|
1218 participants
n=5 Participants
|
|
Quit History : Reasons motivated participant to quit smoking
Family / Friends
|
902 participants
n=5 Participants
|
|
Quit History : Reasons motivated participant to quit smoking
Money / cost
|
72 participants
n=5 Participants
|
|
Quit History : Reasons motivated participant to quit smoking
Body image / appearance
|
78 participants
n=5 Participants
|
|
Quit History : Reasons motivated participant to quit smoking
Smoking ban in public places
|
37 participants
n=5 Participants
|
|
Fagerstrom Test of Nicotine Dependence (FTND)
|
5.50 Scores on a scale
STANDARD_DEVIATION 2.43 • n=5 Participants
|
|
Exhaled Carbon monoxide (CO) level
|
14.20 parts per million (ppm)
STANDARD_DEVIATION 7.69 • n=5 Participants
|
|
Average number of cigarettes smoked per day in the previous 7 day period at baseline
|
20.0 cigarettes
n=5 Participants
|
|
Smoking related concurrent diseases
Occlusive disease of non-coronary arteries(n=1183)
|
21 participants
n=5 Participants
|
|
Smoking related concurrent diseases
Atherosclerotic vascular disease (n=1181)
|
138 participants
n=5 Participants
|
|
Cardiovascular risk factors
Family history of Cardiovascular disease or stroke
|
111 participants
n=5 Participants
|
|
Cardiovascular risk factors
Left ventricular hypertrophy
|
13 participants
n=5 Participants
|
|
Cardiovascular risk factors
Unspecified
|
13 participants
n=5 Participants
|
|
Cardiovascular risk factors
History of microalbuminuria
|
9 participants
n=5 Participants
|
|
Cardiovascular risk factors
Documented Ankle Brachial Index (ABI) <0.9
|
3 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Married
|
1124 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Never Married
|
104 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Divorced
|
13 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Widowed
|
12 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Separated
|
4 participants
n=5 Participants
|
|
Participant social status : Current Marital Status
Cohabitating
|
1 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Living with a spouse or significant other
|
1002 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Living with other family member(s) or roommate(s)
|
193 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Living alone
|
45 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Living in residential treatment center
|
1 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Living in institution
|
1 participants
n=5 Participants
|
|
Participant social status : Current Living Situation
Other unspecified
|
1 participants
n=5 Participants
|
|
Healthcare utilization status: Reimbursement type
Private Insurance
|
111 participants
n=5 Participants
|
|
Healthcare utilization status: Reimbursement type
No Insurance
|
276 participants
n=5 Participants
|
|
Healthcare utilization status: Reimbursement type
Public Insurance
|
877 participants
n=5 Participants
|
|
Healthcare utilization status: Reimbursement type
Other unspecified
|
23 participants
n=5 Participants
|
|
Health care utilization: Employment status
Not employed
|
235 participants
n=5 Participants
|
|
Health care utilization: Employment status
Full-time employed
|
1016 participants
n=5 Participants
|
|
Health care utilization: Employment status
Part-time employed
|
15 participants
n=5 Participants
|
|
Family history of mental illness
Alcohol abuse (n=122)
|
12 participants
n=5 Participants
|
|
Family history of mental illness
Cerebral apoplexy (n=1)
|
1 participants
n=5 Participants
|
|
Family history of mental illness
Dementia (n=120)
|
2 participants
n=5 Participants
|
|
Family history of mental illness
Depression (Chronic or recurrent) (n=119)
|
2 participants
n=5 Participants
|
|
Family history of mental illness
Dissociative disorder (n=1)
|
1 participants
n=5 Participants
|
|
Family history of mental illness
Major depression (n=120)
|
1 participants
n=5 Participants
|
|
Family history of mental illness
Mental disorder (n=1)
|
1 participants
n=5 Participants
|
|
Family history of mental illness
Nicotine addiction (n=8)
|
8 participants
n=5 Participants
|
|
Family history of mental illness
Parkinson's disease (n=1)
|
1 participants
n=5 Participants
|
|
Family history of mental illness
Schizophrenia (n=120)
|
4 participants
n=5 Participants
|
|
Nondrug treatments / procedures for primary diagnosis
Smoking Cessation Counseling
|
661 participants
n=5 Participants
|
|
Nondrug treatments / procedures for primary diagnosis
Quit Smoking Clinic
|
190 participants
n=5 Participants
|
|
Nondrug treatments / procedures for primary diagnosis
Other unspecified
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Acamprosate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Acarbose
|
14 participants
n=5 Participants
|
|
Prior Drug Treatment
Aceclofenac
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Acetylcarnitine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Acetylcysteine
|
11 participants
n=5 Participants
|
|
Prior Drug Treatment
Acetylsalicylic acid
|
99 participants
n=5 Participants
|
|
Prior Drug Treatment
Acetylsalicylic acid/atorvastatin/ramipril
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Acetylsalicylic acid/clopidogrel
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Adenine/biphenyldimethyldicarboxylate/vitamins
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Alfuzosin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
All other therapeutic products
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Allopurinol
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Almagate
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Alprazolam
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Ambroxol
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Ambroxol acefyllinate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ambroxol hydrochloride
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Aminophylline
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amisulpride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Amitriptyline hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine
|
17 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine besilate
|
17 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine besilate/atorvastatin calcium
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine besylate/valsartan
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine camsilate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine maleate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine orotate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Amlodipine/valsartan
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Amoxicillin
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Amoxicillin sodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Antisterone
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Aripiprazole
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Aronamin gold
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Arotinolol hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Artemisia asiatica
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Artemisia asiatica/ethanol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Asmeton
|
9 participants
n=5 Participants
|
|
Prior Drug Treatment
Atenolol
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Atorvastatin
|
44 participants
n=5 Participants
|
|
Prior Drug Treatment
Atorvastatin calcium
|
9 participants
n=5 Participants
|
|
Prior Drug Treatment
Azathioprine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Azelastine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Azelastine hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Azithromycin
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Aztreonam
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
B-komplex "leciva"
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bambuterol hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Becosules syrup
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Becosym forte
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Becotal
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Benazepril
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Benazepril hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Benproperine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Benproperine phosphate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bepotastine besilate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Beraprost
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Betahistine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bevantolol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Biphenyl dimethyl dicarboxylate/garlic
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Biselect
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bismuth subcitrate tripotassium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bismuth subcitrate tripotassium/ranitidine HCl
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Bisoprolol
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Bisoprolol fumarate
|
12 participants
n=5 Participants
|
|
Prior Drug Treatment
Borneol/notoginseng/salvia miltiorrhiza
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bromelains/dehydrocholic/pancreatin/simeticone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Broncho-vaxom
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Budesonide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Bupropion
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Bupropion hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Buspiron
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Buspirone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Calcium chloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Calcium citrate/colecalciferol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Calcium lactate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Candesartan
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Candesartan cilexetil
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Carbazochrome
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cardiovascular system drugs
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Carvedilol
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefaclor
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefoperazone sodium
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefpodoxime
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefpodoxime proxetil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefradine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ceftriaxone sodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefuroxime
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Cefuroxime sodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cephalosporins and related substances
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Cetirizine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Chlormadinone acetate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Choline alfoscerate
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Chondroitin/glucosamine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cilazapril
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Cilnidipine
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Cilostazol
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Cimetidine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ciprofloxacin
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Citalopram
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Clarithromycin
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Clobazam
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Clonazepam
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Clopidogrel
|
19 participants
n=5 Participants
|
|
Prior Drug Treatment
Clopidogrel sulfate
|
16 participants
n=5 Participants
|
|
Prior Drug Treatment
Co-diovan
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Colchicine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Cordalin /old form
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Cough syrup
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Dexamethasone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Dexamethasone/neomycin sulfate/polymyxin B sulfate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Diacerein
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Diazepam
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Diclofenac
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Digoxin
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Dihydrocodeine bitartrate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Diltiazem
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Diltiazem hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Dimenhydrinate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Diprophylline
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Disulfiram
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Domperidone
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Donepezil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Doxazosin mesilate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Doxofylline
|
14 participants
n=5 Participants
|
|
Prior Drug Treatment
Drug, unspecified
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Duloxetine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ecabet monosodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Efavirenz/emtricitabine/tenofovir
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Efonidipine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Enalapril
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Enalapril maleate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Enzymes
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Epoprostenol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Eprosartan
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Eprosartan mesilate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Eprosartan mesilate/hydrochlorothiazide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Erdosteine
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Ergenyl chrono
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Erlotinib hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Erythromycin ethylsuccinate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Escitalopram
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Esomeprazole
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Esomeprazole magnesium
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Etizolam
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Etoposide
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Etoricoxib
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ezetimibe
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ezetimibe/simvastatin
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Famotidine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Felodipine
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Fenofibrate
|
10 participants
n=5 Participants
|
|
Prior Drug Treatment
Ferric hydroxide polymaltose complex
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ferrous sulfate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Fexofenadine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Fish oil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Flumazenil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Flunarizine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Fluoxetine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Folic acid
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Formoterol
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Formoterol fumarate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Fosinopril
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Fosinopril sodium
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Furosemide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Gabapentin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Gefarnate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
General nutrients/herbal NOS
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ginkgo biloba
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Glibenclamide
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Gliclazide
|
10 participants
n=5 Participants
|
|
Prior Drug Treatment
Glimepiride
|
12 participants
n=5 Participants
|
|
Prior Drug Treatment
Glimepiride/metformin hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Glipizide
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Gliquidone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Glucose
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Glyceryl trinitrate
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Guaifenesin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Hedera helix
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Herbal preparation
|
13 participants
n=5 Participants
|
|
Prior Drug Treatment
Homeopatic preparation
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Hyaluronate sodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Hydrochlorothiazide
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Hydrocortisone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Hydrotalcite
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Hyzaar
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Indapamide
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Indometacin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Infliximab
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Inosine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin aspart
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin glargine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin glulisine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin human
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Insulin human injection, isophane
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Ipratropium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ipratropium bromide
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Irbesartan
|
13 participants
n=5 Participants
|
|
Prior Drug Treatment
Isosorbide dinitrate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Isosorbide mononitrate
|
11 participants
n=5 Participants
|
|
Prior Drug Treatment
Isotretinoin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Itavastatin
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Itopride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Itopride hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Karvea hct
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Kombipak II
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lacidipine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lactitol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lamivudine
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Lansoprazole
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lekovit Ca
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Lercanidipine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lercanidipine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Levamlodipine besylate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Levocloperastine fendizoate
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Levodropropizine
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Levofloxacin
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Levofloxacin hydrochloride
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Levosalbutamol hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Levosulpiride
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Levothyroxine sodium
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Liquorice
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lisinopril
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Lithium carbonate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Loratadine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Lorazepam
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Losartan
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Losartan potassium
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Magnesium hydroxide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Mecobalamin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Medilac-S
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Mesalazine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Metformin
|
29 participants
n=5 Participants
|
|
Prior Drug Treatment
Metformin hydrochloride
|
15 participants
n=5 Participants
|
|
Prior Drug Treatment
Metformin hydrochloride/rosiglitazone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Metformin hydrochloride/sitagliptin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Methoxyphenamine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Methylprednisolone
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Metoprolol
|
11 participants
n=5 Participants
|
|
Prior Drug Treatment
Metoprolol succinate
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Metoprolol tartrate
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Midazolam
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Milnacipran hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Mirtazapine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Molsidomine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Mometasone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Montelukast
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Montelukast sodium
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Mosapride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Mosapride citrate
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Moxifloxacin hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Multivitamins, plain
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Myrtol
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Naltrexone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Nateglinide
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Nebivolol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Nicorandil
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Nicotinic acid
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Nifedipine
|
16 participants
n=5 Participants
|
|
Prior Drug Treatment
Nimodipine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Nisoldipine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Nitrendipine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Olanzapine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Olmesartan
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Orlistat
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Oxazepam
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Oxcarbazepine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Oxycodone hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pantoprazole
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pantoprazole sodium
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Paracetamol
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Paroxetine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Paroxetine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Penicillin NOS
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Perindopril
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Pethidine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Phenytoin sodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Phosphatidyl choline
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pioglitazone
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Pioglitazone hydrochloride
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Pip/tazo
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Platelets, human blood
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Polycarbophil calcium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pranlukast hydrate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pravastatin
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Pravastatin sodium
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Prednisolone
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Pregabalin
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Procaterol
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Propranolol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Propranolol hydrochloride
|
1 participants
n=5 Participants
|
|
Medical History
Asthma
|
65 participants
n=5 Participants
|
|
Medical History
Bronchitis chronic
|
19 participants
n=5 Participants
|
|
Prior Drug Treatment
Pseudoephedrine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Pyridoxine hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Quetiapine fumarate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Rabeprazole
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Rabeprazole sodium
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Ramipril
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Ranitidine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ranitidine hydrochloride
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Rebamipide
|
12 participants
n=5 Participants
|
|
Prior Drug Treatment
Repaglinide
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Risedronic acid
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Risperidone
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Rosiglitazone maleate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Rosuvastatin
|
14 participants
n=5 Participants
|
|
Prior Drug Treatment
Rosuvastatin calcium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Roxithromycin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Salbutamol
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Salbutamol sulfate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Salmeterol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Salmeterol xinafoate
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Salvia miltiorrhiza
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sarpogrelate hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Selective beta-2-adrenoreceptor agonists
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Selegiline hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Seretide mite
|
15 participants
n=5 Participants
|
|
Prior Drug Treatment
Sertraline
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sibutramine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sildenafil citrate
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Silymarin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Simvastatin
|
19 participants
n=5 Participants
|
|
Prior Drug Treatment
Sinemet
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sinilgel
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sitagliptin
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Sodium chloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sotalol hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Spironolactone
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Streptomycin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sucralfate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Sulglicotide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Sulodexide
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Symbicort turbuhaler "draco"
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Tamsulosin
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Tamsulosin hydrochloride
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Tazobactam sodium
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Telmisartan
|
8 participants
n=5 Participants
|
|
Prior Drug Treatment
Terazosin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Terazosin hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Terbutaline sulfate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Theophylline
|
7 participants
n=5 Participants
|
|
Prior Drug Treatment
Thiamazole
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Thioctic acid
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Throat preparations
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Tianeptine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ticlopidine
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Tiotropium
|
10 participants
n=5 Participants
|
|
Prior Drug Treatment
Tiotropium bromide
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Tiotropium bromide/formoterol fumarate
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Tiropramide hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Tocopherol
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Tramadol hydrochloride
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Tranexamic acid
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Travad phosphate enema
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Trazodone
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Triaprin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Triflusal
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Trimetazidine
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Trimetazidine hydrochloride
|
2 participants
n=5 Participants
|
|
Prior Drug Treatment
Udenafil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Ultracet
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Ursodeoxycholic acid
|
4 participants
n=5 Participants
|
|
Prior Drug Treatment
Valproate semisodium
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Valsartan
|
9 participants
n=5 Participants
|
|
Prior Drug Treatment
Verapamil
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Vildagliptin
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Vitamins
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Vitamins with minerals
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Voglibose
|
3 participants
n=5 Participants
|
|
Prior Drug Treatment
Warfarin
|
6 participants
n=5 Participants
|
|
Prior Drug Treatment
Yeast
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Zevit
|
1 participants
n=5 Participants
|
|
Prior Drug Treatment
Zolpidem
|
5 participants
n=5 Participants
|
|
Prior Drug Treatment
Zolpidem tartrate
|
3 participants
n=5 Participants
|
|
Medical History
Acute myocardial infarction
|
2 participants
n=5 Participants
|
|
Medical History
Angina pectoris
|
18 participants
n=5 Participants
|
|
Medical History
Arrhythmia
|
3 participants
n=5 Participants
|
|
Medical History
Arteriosclerosis coronary artery
|
1 participants
n=5 Participants
|
|
Medical History
Atrial fibrillation
|
5 participants
n=5 Participants
|
|
Medical History
Bundle branch block right
|
1 participants
n=5 Participants
|
|
Medical History
Cardiac failure
|
1 participants
n=5 Participants
|
|
Medical History
Cardiac failure congestive
|
2 participants
n=5 Participants
|
|
Medical History
Cardiac valve disease
|
1 participants
n=5 Participants
|
|
Medical History
Congestive cardiomyopathy
|
1 participants
n=5 Participants
|
|
Medical History
Cor pulmonale chronic
|
1 participants
n=5 Participants
|
|
Medical History
Coronary artery disease
|
72 participants
n=5 Participants
|
|
Medical History
Coronary artery stenosis
|
1 participants
n=5 Participants
|
|
Medical History
Left ventricular hypertrophy
|
1 participants
n=5 Participants
|
|
Medical History
Mitral valve calcification
|
1 participants
n=5 Participants
|
|
Medical History
Myocardial infarction
|
1 participants
n=5 Participants
|
|
Medical History
Myocardial ischaemia
|
1 participants
n=5 Participants
|
|
Medical History
Prinzmetal angina
|
2 participants
n=5 Participants
|
|
Medical History
Sinus tachycardia
|
1 participants
n=5 Participants
|
|
Medical History
Ventricular extrasystoles
|
1 participants
n=5 Participants
|
|
Medical History
Hearing impaired
|
1 participants
n=5 Participants
|
|
Medical History
Basedow's disease
|
2 participants
n=5 Participants
|
|
Medical History
Goitre
|
1 participants
n=5 Participants
|
|
Medical History
Hyperthyroidism
|
3 participants
n=5 Participants
|
|
Medical History
Hypothyroidism
|
5 participants
n=5 Participants
|
|
Medical History
Thyroid cyst
|
1 participants
n=5 Participants
|
|
Medical History
Blindness unilateral
|
1 participants
n=5 Participants
|
|
Medical History
Visual impairment
|
1 participants
n=5 Participants
|
|
Medical History
Abdominal discomfort
|
1 participants
n=5 Participants
|
|
Medical History
Abdominal pain upper
|
1 participants
n=5 Participants
|
|
Medical History
Colitis
|
1 participants
n=5 Participants
|
|
Medical History
Colonic polyp
|
3 participants
n=5 Participants
|
|
Medical History
Constipation
|
3 participants
n=5 Participants
|
|
Medical History
Crohn's disease
|
1 participants
n=5 Participants
|
|
Medical History
Diverticulum intestinal
|
1 participants
n=5 Participants
|
|
Medical History
Duodenal ulcer
|
6 participants
n=5 Participants
|
|
Medical History
Duodenitis
|
1 participants
n=5 Participants
|
|
Medical History
Dyspepsia
|
5 participants
n=5 Participants
|
|
Medical History
Gastric haemorrhage
|
1 participants
n=5 Participants
|
|
Medical History
Gastric ulcer
|
6 participants
n=5 Participants
|
|
Medical History
Gastritis
|
53 participants
n=5 Participants
|
|
Medical History
Gastritis atrophic
|
4 participants
n=5 Participants
|
|
Medical History
Gastritis erosive
|
4 participants
n=5 Participants
|
|
Medical History
Gastrooesophageal reflux disease
|
11 participants
n=5 Participants
|
|
Medical History
Haemorrhoids
|
1 participants
n=5 Participants
|
|
Medical History
Intestinal polyp
|
1 participants
n=5 Participants
|
|
Medical History
Irritable bowel syndrome
|
2 participants
n=5 Participants
|
|
Medical History
Nausea
|
1 participants
n=5 Participants
|
|
Medical History
Oesophagitis
|
2 participants
n=5 Participants
|
|
Medical History
Pancreatitis
|
2 participants
n=5 Participants
|
|
Medical History
Pancreatitis chronic
|
1 participants
n=5 Participants
|
|
Medical History
Peptic ulcer
|
50 participants
n=5 Participants
|
|
Medical History
Periodontitis
|
1 participants
n=5 Participants
|
|
Medical History
Reflux oesophagitis
|
11 participants
n=5 Participants
|
|
Medical History
Chest pain
|
2 participants
n=5 Participants
|
|
Medical History
Fatigue
|
3 participants
n=5 Participants
|
|
Medical History
Malaise
|
1 participants
n=5 Participants
|
|
Medical History
Pain
|
1 participants
n=5 Participants
|
|
Medical History
Alcoholic liver disease
|
1 participants
n=5 Participants
|
|
Medical History
Cholecystitis
|
2 participants
n=5 Participants
|
|
Medical History
Cholelithiasis
|
1 participants
n=5 Participants
|
|
Medical History
Chronic hepatitis
|
2 participants
n=5 Participants
|
|
Medical History
Hepatic cyst
|
1 participants
n=5 Participants
|
|
Medical History
Hepatic steatosis
|
12 participants
n=5 Participants
|
|
Medical History
Hepatitis
|
2 participants
n=5 Participants
|
|
Medical History
Hepatitis alcoholic
|
1 participants
n=5 Participants
|
|
Medical History
Behcet's syndrome
|
1 participants
n=5 Participants
|
|
Medical History
Sarcoidosis
|
1 participants
n=5 Participants
|
|
Medical History
Appendicitis
|
1 participants
n=5 Participants
|
|
Medical History
Body tinea
|
1 participants
n=5 Participants
|
|
Medical History
Bronchiectasis
|
5 participants
n=5 Participants
|
|
Medical History
Bronchitis
|
15 participants
n=5 Participants
|
|
Medical History
Chronic sinusitis
|
1 participants
n=5 Participants
|
|
Medical History
Cystitis
|
1 participants
n=5 Participants
|
|
Medical History
Helicobacter infection
|
1 participants
n=5 Participants
|
|
Medical History
Hepatitis B
|
3 participants
n=5 Participants
|
|
Medical History
Lower respiratory tract infection
|
1 participants
n=5 Participants
|
|
Medical History
Lung abscess
|
1 participants
n=5 Participants
|
|
Medical History
Nasopharyngitis
|
1 participants
n=5 Participants
|
|
Medical History
Onychomycosis
|
1 participants
n=5 Participants
|
|
Medical History
Pharyngitis
|
12 participants
n=5 Participants
|
|
Medical History
Pneumonia
|
7 participants
n=5 Participants
|
|
Medical History
Pulmonary tuberculosis
|
8 participants
n=5 Participants
|
|
Medical History
Pyelonephritis acute
|
1 participants
n=5 Participants
|
|
Medical History
Rhinitis
|
7 participants
n=5 Participants
|
|
Medical History
Tinea pedis
|
2 participants
n=5 Participants
|
|
Medical History
Tonsillitis
|
1 participants
n=5 Participants
|
|
Medical History
Tuberculosis
|
3 participants
n=5 Participants
|
|
Medical History
Tuberculosis gastrointestinal
|
1 participants
n=5 Participants
|
|
Medical History
Tuberculous pleurisy
|
2 participants
n=5 Participants
|
|
Medical History
Upper respiratory tract infection
|
2 participants
n=5 Participants
|
|
Medical History
Meniscus lesion
|
1 participants
n=5 Participants
|
|
Medical History
Blood cholesterol increased
|
1 participants
n=5 Participants
|
|
Medical History
Blood viscosity increased
|
1 participants
n=5 Participants
|
|
Medical History
HIV test positive
|
1 participants
n=5 Participants
|
|
Medical History
Hepatitis B virus test
|
1 participants
n=5 Participants
|
|
Medical History
Liver function test abnormal
|
1 participants
n=5 Participants
|
|
Medical History
Calcium deficiency
|
1 participants
n=5 Participants
|
|
Medical History
Diabetes mellitus
|
132 participants
n=5 Participants
|
|
Medical History
Dyslipidaemia
|
167 participants
n=5 Participants
|
|
Medical History
Gout
|
1 participants
n=5 Participants
|
|
Medical History
Hypercholesterolaemia
|
2 participants
n=5 Participants
|
|
Medical History
Hyperhomocysteinaemia
|
1 participants
n=5 Participants
|
|
Medical History
Hyperlipidaemia
|
19 participants
n=5 Participants
|
|
Medical History
Hyperuricaemia
|
5 participants
n=5 Participants
|
|
Medical History
Impaired fasting glucose
|
1 participants
n=5 Participants
|
|
Medical History
Iron deficiency
|
1 participants
n=5 Participants
|
|
Medical History
Obesity
|
7 participants
n=5 Participants
|
|
Medical History
Ankylosing spondylitis
|
1 participants
n=5 Participants
|
|
Medical History
Arthritis
|
1 participants
n=5 Participants
|
|
Medical History
Back pain
|
1 participants
n=5 Participants
|
|
Medical History
Intervertebral disc disorder
|
1 participants
n=5 Participants
|
|
Medical History
Neck pain
|
1 participants
n=5 Participants
|
|
Medical History
Osteoarthritis
|
2 participants
n=5 Participants
|
|
Medical History
Osteopenia
|
1 participants
n=5 Participants
|
|
Medical History
Osteoporosis
|
4 participants
n=5 Participants
|
|
Medical History
Rheumatoid arthritis
|
4 participants
n=5 Participants
|
|
Medical History
Acute lymphocytic leukaemia
|
1 participants
n=5 Participants
|
|
Medical History
Benign lung neoplasm
|
1 participants
n=5 Participants
|
|
Medical History
Brain neoplasm
|
1 participants
n=5 Participants
|
|
Medical History
Cervix carcinoma
|
1 participants
n=5 Participants
|
|
Medical History
Extranodal marginal zone B-cell lymphoma
|
1 participants
n=5 Participants
|
|
Medical History
Gastric adenoma
|
1 participants
n=5 Participants
|
|
Medical History
Gastric cancer
|
1 participants
n=5 Participants
|
|
Medical History
Head and neck cancer
|
2 participants
n=5 Participants
|
|
Medical History
Chronic obstructive pulmonary disease
|
116 participants
n=5 Participants
|
|
Medical History
Hepatic neoplasm malignant
|
1 participants
n=5 Participants
|
|
Medical History
Histiocytosis haematophagic
|
1 participants
n=5 Participants
|
|
Medical History
Laryngeal cancer
|
1 participants
n=5 Participants
|
|
Medical History
Leiomyosarcoma
|
1 participants
n=5 Participants
|
|
Medical History
Lung neoplasm
|
9 participants
n=5 Participants
|
|
Medical History
Lung neoplasm malignant
|
8 participants
n=5 Participants
|
|
Medical History
Prostate cancer
|
1 participants
n=5 Participants
|
|
Medical History
Rectal cancer
|
2 participants
n=5 Participants
|
|
Medical History
Renal cancer
|
2 participants
n=5 Participants
|
|
Medical History
Renal cell carcinoma
|
1 participants
n=5 Participants
|
|
Medical History
Renal neoplasm
|
1 participants
n=5 Participants
|
|
Medical History
Carotid artery occlusion
|
1 participants
n=5 Participants
|
|
Medical History
Carotid artery stenosis
|
3 participants
n=5 Participants
|
|
Medical History
Cerebral arteriosclerosis
|
1 participants
n=5 Participants
|
|
Medical History
Cerebral infarction
|
4 participants
n=5 Participants
|
|
Medical History
Cerebral ischaemia
|
1 participants
n=5 Participants
|
|
Medical History
Cerebrovascular accident
|
21 participants
n=5 Participants
|
|
Medical History
Dementia
|
1 participants
n=5 Participants
|
|
Medical History
Dizziness
|
2 participants
n=5 Participants
|
|
Medical History
Headache
|
6 participants
n=5 Participants
|
|
Medical History
Myasthenia gravis
|
1 participants
n=5 Participants
|
|
Medical History
Neuropathy peripheral
|
1 participants
n=5 Participants
|
|
Medical History
Parkinson's disease
|
1 participants
n=5 Participants
|
|
Medical History
Sedation
|
1 participants
n=5 Participants
|
|
Medical History
Transient ischaemic attack
|
2 participants
n=5 Participants
|
|
Medical History
Alcohol abuse
|
46 participants
n=5 Participants
|
|
Medical History
Bipolar disorder
|
2 participants
n=5 Participants
|
|
Medical History
Depressed mood
|
1 participants
n=5 Participants
|
|
Medical History
Depression
|
8 participants
n=5 Participants
|
|
Medical History
Dysthymic disorder
|
1 participants
n=5 Participants
|
|
Medical History
Generalised anxiety disorder
|
11 participants
n=5 Participants
|
|
Medical History
Insomnia
|
5 participants
n=5 Participants
|
|
Medical History
Major depression
|
17 participants
n=5 Participants
|
|
Medical History
Obsessive-compulsive disorder
|
1 participants
n=5 Participants
|
|
Medical History
Panic attack
|
5 participants
n=5 Participants
|
|
Medical History
Panic disorder
|
6 participants
n=5 Participants
|
|
Medical History
Personality disorder
|
5 participants
n=5 Participants
|
|
Medical History
Psychotic disorder
|
1 participants
n=5 Participants
|
|
Medical History
Schizoaffective disorder
|
1 participants
n=5 Participants
|
|
Medical History
Schizophrenia
|
3 participants
n=5 Participants
|
|
Medical History
Sleep disorder
|
4 participants
n=5 Participants
|
|
Medical History
Cough
|
6 participants
n=5 Participants
|
|
Medical History
Dyspnoea
|
3 participants
n=5 Participants
|
|
Medical History
Emphysema
|
7 participants
n=5 Participants
|
|
Medical History
Epistaxis
|
1 participants
n=5 Participants
|
|
Medical History
Haemoptysis
|
3 participants
n=5 Participants
|
|
Medical History
Idiopathic pulmonary fibrosis
|
1 participants
n=5 Participants
|
|
Medical History
Interstitial lung disease
|
3 participants
n=5 Participants
|
|
Medical History
Pleural effusion
|
1 participants
n=5 Participants
|
|
Medical History
Pneumothorax
|
1 participants
n=5 Participants
|
|
Medical History
Pulmonary bulla
|
1 participants
n=5 Participants
|
|
Medical History
Pulmonary embolism
|
1 participants
n=5 Participants
|
|
Medical History
Pulmonary mass
|
3 participants
n=5 Participants
|
|
Medical History
Respiratory disorder
|
2 participants
n=5 Participants
|
|
Medical History
Rhinitis allergic
|
7 participants
n=5 Participants
|
|
Medical History
Sleep apnoea syndrome
|
5 participants
n=5 Participants
|
|
Medical History
Snoring
|
1 participants
n=5 Participants
|
|
Medical History
Acne
|
1 participants
n=5 Participants
|
|
Medical History
Alopecia areata
|
1 participants
n=5 Participants
|
|
Medical History
Dermatitis contact
|
1 participants
n=5 Participants
|
|
Medical History
Pruritus
|
1 participants
n=5 Participants
|
|
Medical History
Urticaria
|
1 participants
n=5 Participants
|
|
Medical History
Alcoholic
|
1 participants
n=5 Participants
|
|
Medical History
Aortic valve replacement
|
1 participants
n=5 Participants
|
|
Medical History
Haemorrhoid operation
|
1 participants
n=5 Participants
|
|
Medical History
Arteriosclerosis
|
2 participants
n=5 Participants
|
|
Medical History
Hypertension
|
229 participants
n=5 Participants
|
|
Medical History
Peripheral vascular disorder
|
2 participants
n=5 Participants
|
|
Medical History
Thromboangiitis obliterans
|
2 participants
n=5 Participants
|
|
Medical History
Vasculitis
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all participants who received at least 1 dose of study medication
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Percentage of Participants With Smoking Abstinence at Week 12
|
46.40 percentage of participants
Interval 43.73 to 49.07
|
SECONDARY outcome
Timeframe: Last observed study visit (Week 12 or early termination [ET])Population: FAS included all participants who received at least 1 dose of study medication.
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
|
50.30 percentage of participants
Interval 47.58 to 52.93
|
SECONDARY outcome
Timeframe: Week 3 through Week 11Population: At Week t (t = 3 to 11), the analysis population was "Observed Cases minus Week t" (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values.
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 3 (n= 677)
|
31.3 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 4 (n= 799)
|
38.2 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 5 (n= 988)
|
45.4 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 6 (n= 959)
|
47.8 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 7 (n= 888)
|
49.5 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 8 (n= 812)
|
51.6 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 9 (n= 765)
|
55.2 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 10 (n= 702)
|
55.4 percentage of participants
|
|
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Week 11 (n= 605)
|
59.2 percentage of participants
|
SECONDARY outcome
Timeframe: Last observed study visit (Week 12 or ET)Population: FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115).
The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.
Outcome measures
| Measure |
Varenicline
n=115 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
CO Level at Last Observed Study Visit
|
4.1 ppm
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: Last observed study visit (Week 12 or ET)Population: FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518).
The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).
Outcome measures
| Measure |
Varenicline
n=518 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
|
10.0 cigarettes
Full Range 9.57 • Interval 1.0 to 80.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After last observed study visit (Week 12 or ET)Population: FAS population included all participants who received at least 1 dose of study medication.
Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Varenicline Prescription Status
Prescription status = Yes
|
145 participants
|
|
Varenicline Prescription Status
Prescription status = No
|
962 participants
|
|
Varenicline Prescription Status
Prescription status = Unknown
|
266 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)Population: FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Average Daily Dose of Varenicline
Days 1-3
|
0.5 mg
Full Range 0.13 • Interval 0.5 to 2.0
|
|
Average Daily Dose of Varenicline
Days 4-7 (n=1347)
|
1.0 mg
Full Range 0.21 • Interval 0.5 to 2.0
|
|
Average Daily Dose of Varenicline
Day 8 - Last observed study visit (n=1284)
|
2.0 mg
Full Range 0.27 • Interval 0.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through last observed study visit (Week 12 or ET)Population: FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis.
The duration was defined as the total number of dosing days from first to last day of each study treatment.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Median Duration of Treatment of Varenicline
|
43.0 Days
Interval 1.0 to 271.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Last observed study visit (Week 12 or ET)Population: FAS included all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
Varenicline
n=1373 Participants
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Concomitant Drug Treatments
Acamprosate
|
5 Participants
|
|
Concomitant Drug Treatments
Acarbose
|
17 Participants
|
|
Concomitant Drug Treatments
Aceclofenac
|
1 Participants
|
|
Concomitant Drug Treatments
Acetylcarnitine
|
2 Participants
|
|
Concomitant Drug Treatments
Acetylcysteine
|
14 Participants
|
|
Concomitant Drug Treatments
Acetylsalicylic acid
|
110 Participants
|
|
Concomitant Drug Treatments
Acetylsalicylic acid/atorvastatin/ramipril
|
1 Participants
|
|
Concomitant Drug Treatments
Acetylsalicylic acid/clopidogrel
|
1 Participants
|
|
Concomitant Drug Treatments
Adenine/biphenyldimethyldicarboxylate/vitamins
|
1 Participants
|
|
Concomitant Drug Treatments
Albumin human
|
1 Participants
|
|
Concomitant Drug Treatments
Alfuzosin
|
1 Participants
|
|
Concomitant Drug Treatments
All other therapeutic products
|
11 Participants
|
|
Concomitant Drug Treatments
Allopurinol
|
2 Participants
|
|
Concomitant Drug Treatments
Almagate
|
8 Participants
|
|
Concomitant Drug Treatments
Almagel
|
1 Participants
|
|
Concomitant Drug Treatments
Alprazolam
|
8 Participants
|
|
Concomitant Drug Treatments
Aluminum hydroxide/magnesium carbonate
|
1 Participants
|
|
Concomitant Drug Treatments
Amantadine hydrochloride / paracetamol
|
1 Participants
|
|
Concomitant Drug Treatments
Ambroxol
|
3 Participants
|
|
Concomitant Drug Treatments
Ambroxol acefyllinate
|
3 Participants
|
|
Concomitant Drug Treatments
Ambroxol hydrochloride
|
4 Participants
|
|
Concomitant Drug Treatments
Amikacin
|
1 Participants
|
|
Concomitant Drug Treatments
Amino acids
|
2 Participants
|
|
Concomitant Drug Treatments
Amino acids NOS/carbohydrates NOS/electrolytes NOS
|
1 Participants
|
|
Concomitant Drug Treatments
Aminophylline
|
1 Participants
|
|
Concomitant Drug Treatments
Amisulpride
|
2 Participants
|
|
Concomitant Drug Treatments
Amitriptyline hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Amlodipine
|
18 Participants
|
|
Concomitant Drug Treatments
Amlodipine besilate
|
21 Participants
|
|
Concomitant Drug Treatments
Amlodipine besilate/atorvastatin calcium
|
3 Participants
|
|
Concomitant Drug Treatments
Amlodipine besilate/valsartan
|
2 Participants
|
|
Concomitant Drug Treatments
Amlodipine camsilate
|
2 Participants
|
|
Concomitant Drug Treatments
Amlodipine maleate
|
2 Participants
|
|
Concomitant Drug Treatments
Amlodipine orotate
|
2 Participants
|
|
Concomitant Drug Treatments
Amlodipine/valsartan
|
3 Participants
|
|
Concomitant Drug Treatments
Ammonium Cl/chlorpheniramine maleate
|
1 Participants
|
|
Concomitant Drug Treatments
Amoxicillin
|
1 Participants
|
|
Concomitant Drug Treatments
Amoxicillin sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Anisodamine
|
1 Participants
|
|
Concomitant Drug Treatments
Antacids
|
1 Participants
|
|
Concomitant Drug Treatments
Antidiarrhoeal microorganisms
|
1 Participants
|
|
Concomitant Drug Treatments
Antisterone
|
2 Participants
|
|
Concomitant Drug Treatments
Aripiprazole
|
1 Participants
|
|
Concomitant Drug Treatments
Aronamin gold
|
1 Participants
|
|
Concomitant Drug Treatments
Arotinolol hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Artemisia asiatica
|
1 Participants
|
|
Concomitant Drug Treatments
Artemisia asiatica/ethanol
|
1 Participants
|
|
Concomitant Drug Treatments
Asasantin
|
1 Participants
|
|
Concomitant Drug Treatments
Asmeton
|
8 Participants
|
|
Concomitant Drug Treatments
Atenolol
|
4 Participants
|
|
Concomitant Drug Treatments
Atorvastatin
|
54 Participants
|
|
Concomitant Drug Treatments
Atorvastatin calcium
|
7 Participants
|
|
Concomitant Drug Treatments
Atorvastatin/fenofibrate
|
2 Participants
|
|
Concomitant Drug Treatments
Azathioprine
|
2 Participants
|
|
Concomitant Drug Treatments
Azelastine
|
2 Participants
|
|
Concomitant Drug Treatments
Azelastine hydrochloride
|
5 Participants
|
|
Concomitant Drug Treatments
Azithromycin
|
6 Participants
|
|
Concomitant Drug Treatments
Aztreonam
|
1 Participants
|
|
Concomitant Drug Treatments
B-komplex "leciva"
|
1 Participants
|
|
Concomitant Drug Treatments
Bambuterol hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Becosules syrup
|
2 Participants
|
|
Concomitant Drug Treatments
Becosym forte
|
1 Participants
|
|
Concomitant Drug Treatments
Becotal
|
1 Participants
|
|
Concomitant Drug Treatments
Benazepril
|
1 Participants
|
|
Concomitant Drug Treatments
Benazepril hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Benexate hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Benproperine
|
1 Participants
|
|
Concomitant Drug Treatments
Benproperine phosphate
|
3 Participants
|
|
Concomitant Drug Treatments
Benzodiazepine derivatives
|
1 Participants
|
|
Concomitant Drug Treatments
Bepotastine besilate
|
2 Participants
|
|
Concomitant Drug Treatments
Beraprost
|
1 Participants
|
|
Concomitant Drug Treatments
Beraprost sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Berberine
|
1 Participants
|
|
Concomitant Drug Treatments
Beszyme
|
1 Participants
|
|
Concomitant Drug Treatments
Betahistine
|
1 Participants
|
|
Concomitant Drug Treatments
Bevantolol
|
1 Participants
|
|
Concomitant Drug Treatments
Biselect
|
1 Participants
|
|
Concomitant Drug Treatments
Bismuth subcitrate tripotassium
|
1 Participants
|
|
Concomitant Drug Treatments
Bismuth subcitrate tripotassium/ranitidine HCl
|
2 Participants
|
|
Concomitant Drug Treatments
Bisoprolol
|
6 Participants
|
|
Concomitant Drug Treatments
Bisoprolol fumarate
|
13 Participants
|
|
Concomitant Drug Treatments
Borneol/notoginseng/salvia miltiorrhiza
|
1 Participants
|
|
Concomitant Drug Treatments
Bromelains/dehydrocholic/pancreatin/simeticone
|
1 Participants
|
|
Concomitant Drug Treatments
Bromhexine
|
3 Participants
|
|
Concomitant Drug Treatments
Broncho-vaxom
|
2 Participants
|
|
Concomitant Drug Treatments
Budesonide
|
4 Participants
|
|
Concomitant Drug Treatments
Bufferin
|
1 Participants
|
|
Concomitant Drug Treatments
Bupropion
|
3 Participants
|
|
Concomitant Drug Treatments
Bupropion hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Buspiron
|
1 Participants
|
|
Concomitant Drug Treatments
Buspirone
|
1 Participants
|
|
Concomitant Drug Treatments
Calcitriol / calcium citrate
|
1 Participants
|
|
Concomitant Drug Treatments
Calcium citrate/colecalciferol
|
1 Participants
|
|
Concomitant Drug Treatments
Calcium lactate
|
1 Participants
|
|
Concomitant Drug Treatments
Candesartan
|
7 Participants
|
|
Concomitant Drug Treatments
Candesartan cilexetil
|
2 Participants
|
|
Concomitant Drug Treatments
Carbazochrome
|
1 Participants
|
|
Concomitant Drug Treatments
Cardiovascular system drugs
|
1 Participants
|
|
Concomitant Drug Treatments
Carvedilol
|
7 Participants
|
|
Concomitant Drug Treatments
Cefaclor
|
3 Participants
|
|
Concomitant Drug Treatments
Cefalexin
|
1 Participants
|
|
Concomitant Drug Treatments
Cefcapene pivoxil hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Cefixime
|
5 Participants
|
|
Concomitant Drug Treatments
Cefoperazone sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Cefpodoxime
|
3 Participants
|
|
Concomitant Drug Treatments
Cefpodoxime proxetil
|
1 Participants
|
|
Concomitant Drug Treatments
Cefradine
|
1 Participants
|
|
Concomitant Drug Treatments
Ceftriaxone
|
1 Participants
|
|
Concomitant Drug Treatments
Ceftriaxone sodium
|
2 Participants
|
|
Concomitant Drug Treatments
Cefuroxime
|
1 Participants
|
|
Concomitant Drug Treatments
Cefuroxime axetil
|
1 Participants
|
|
Concomitant Drug Treatments
Cefuroxime sodium
|
3 Participants
|
|
Concomitant Drug Treatments
Celecoxib
|
1 Participants
|
|
Concomitant Drug Treatments
Cephalosporins and related substances
|
2 Participants
|
|
Concomitant Drug Treatments
Cetirizine
|
1 Participants
|
|
Concomitant Drug Treatments
Chlordiazepoxide/clidinium bromide/dicycloverine
|
4 Participants
|
|
Concomitant Drug Treatments
Chlormadinone acetate
|
1 Participants
|
|
Concomitant Drug Treatments
Chlorphenamine maleate
|
2 Participants
|
|
Concomitant Drug Treatments
Chlorphenesin carbamate
|
1 Participants
|
|
Concomitant Drug Treatments
Choline alfoscerate
|
7 Participants
|
|
Concomitant Drug Treatments
Chondroitin/glucosamine
|
1 Participants
|
|
Concomitant Drug Treatments
Cilazapril
|
2 Participants
|
|
Concomitant Drug Treatments
Cilnidipine
|
7 Participants
|
|
Concomitant Drug Treatments
Cilostazol
|
5 Participants
|
|
Concomitant Drug Treatments
Cimetidine
|
3 Participants
|
|
Concomitant Drug Treatments
Cimetropium bromide
|
1 Participants
|
|
Concomitant Drug Treatments
Cinnarizine
|
1 Participants
|
|
Concomitant Drug Treatments
Ciprofloxacin
|
2 Participants
|
|
Concomitant Drug Treatments
Ciprofloxacin hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Citalopram
|
1 Participants
|
|
Concomitant Drug Treatments
Citicoline
|
1 Participants
|
|
Concomitant Drug Treatments
Clarithromycin
|
4 Participants
|
|
Concomitant Drug Treatments
Clavulin
|
2 Participants
|
|
Concomitant Drug Treatments
Clobazam
|
1 Participants
|
|
Concomitant Drug Treatments
Clonazepam
|
7 Participants
|
|
Concomitant Drug Treatments
Clopidogrel
|
21 Participants
|
|
Concomitant Drug Treatments
Clopidogrel sulfate
|
16 Participants
|
|
Concomitant Drug Treatments
Co-diovan
|
2 Participants
|
|
Concomitant Drug Treatments
Colchicine
|
3 Participants
|
|
Concomitant Drug Treatments
Cordalin/old form/
|
1 Participants
|
|
Concomitant Drug Treatments
Cotylenol
|
1 Participants
|
|
Concomitant Drug Treatments
Cough syrup
|
1 Participants
|
|
Concomitant Drug Treatments
Cyproterone acetate
|
1 Participants
|
|
Concomitant Drug Treatments
Desmopressin
|
1 Participants
|
|
Concomitant Drug Treatments
Desonide
|
1 Participants
|
|
Concomitant Drug Treatments
Dexamethasone
|
3 Participants
|
|
Concomitant Drug Treatments
Dexamethasone/neomycin sulfate/polymyxin B sulfate
|
1 Participants
|
|
Concomitant Drug Treatments
Diazepam
|
4 Participants
|
|
Concomitant Drug Treatments
Diclofenac
|
1 Participants
|
|
Concomitant Drug Treatments
Digoxin
|
3 Participants
|
|
Concomitant Drug Treatments
Dihydrocodeine bitartrate
|
3 Participants
|
|
Concomitant Drug Treatments
Diloxanide furoate/metronidazole
|
1 Participants
|
|
Concomitant Drug Treatments
Diltiazem
|
6 Participants
|
|
Concomitant Drug Treatments
Diltiazem hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Dimenhydrinate
|
1 Participants
|
|
Concomitant Drug Treatments
Disulfiram
|
1 Participants
|
|
Concomitant Drug Treatments
Docetaxel
|
1 Participants
|
|
Concomitant Drug Treatments
Domperidone
|
7 Participants
|
|
Concomitant Drug Treatments
Domperidone maleate
|
1 Participants
|
|
Concomitant Drug Treatments
Domperidone/pantoprazole
|
2 Participants
|
|
Concomitant Drug Treatments
Domperidone/rabeprazole
|
1 Participants
|
|
Concomitant Drug Treatments
Domperidone/rabeprazole sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Donepezil
|
1 Participants
|
|
Concomitant Drug Treatments
Doxazosin
|
1 Participants
|
|
Concomitant Drug Treatments
Doxazosin mesilate
|
1 Participants
|
|
Concomitant Drug Treatments
Doxofylline
|
21 Participants
|
|
Concomitant Drug Treatments
Drotaverine
|
1 Participants
|
|
Concomitant Drug Treatments
Drug, unspecified
|
5 Participants
|
|
Concomitant Drug Treatments
Duloxetine
|
1 Participants
|
|
Concomitant Drug Treatments
Duloxetine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Ebastine
|
2 Participants
|
|
Concomitant Drug Treatments
Ecabet monosodium
|
3 Participants
|
|
Concomitant Drug Treatments
Efavirenz/emtricitabine/tenofovir
|
1 Participants
|
|
Concomitant Drug Treatments
Efonidipine
|
1 Participants
|
|
Concomitant Drug Treatments
Enalapril
|
3 Participants
|
|
Concomitant Drug Treatments
Enalapril maleate
|
1 Participants
|
|
Concomitant Drug Treatments
Epoprostenol
|
1 Participants
|
|
Concomitant Drug Treatments
Eprosartan
|
2 Participants
|
|
Concomitant Drug Treatments
Eprosartan mesilate
|
1 Participants
|
|
Concomitant Drug Treatments
Eprosartan mesilate/hydrochlorothiazide
|
2 Participants
|
|
Concomitant Drug Treatments
Erdosteine
|
14 Participants
|
|
Concomitant Drug Treatments
Ergenyl chrono
|
3 Participants
|
|
Concomitant Drug Treatments
Erlotinib hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Erythromycin ethylsuccinate
|
1 Participants
|
|
Concomitant Drug Treatments
Escitalopram
|
3 Participants
|
|
Concomitant Drug Treatments
Esomeprazole
|
2 Participants
|
|
Concomitant Drug Treatments
Esomeprazole magnesium
|
2 Participants
|
|
Concomitant Drug Treatments
Estazolam
|
1 Participants
|
|
Concomitant Drug Treatments
Etizolam
|
2 Participants
|
|
Concomitant Drug Treatments
Etoposide
|
1 Participants
|
|
Concomitant Drug Treatments
Etoricoxib
|
1 Participants
|
|
Concomitant Drug Treatments
Ezetimibe
|
1 Participants
|
|
Concomitant Drug Treatments
Ezetimibe/simvastatin
|
4 Participants
|
|
Concomitant Drug Treatments
Famotidine
|
2 Participants
|
|
Concomitant Drug Treatments
Felodipine
|
7 Participants
|
|
Concomitant Drug Treatments
Fenofibrate
|
11 Participants
|
|
Concomitant Drug Treatments
Ferric hydroxide polymaltose complex
|
1 Participants
|
|
Concomitant Drug Treatments
Ferrous sulfate
|
1 Participants
|
|
Concomitant Drug Treatments
Fexofenadine
|
3 Participants
|
|
Concomitant Drug Treatments
Fexofenadine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Fish oil
|
1 Participants
|
|
Concomitant Drug Treatments
Flunarizine
|
1 Participants
|
|
Concomitant Drug Treatments
Fluoxetine
|
4 Participants
|
|
Concomitant Drug Treatments
Fluoxetine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Fluticasone propionate
|
1 Participants
|
|
Concomitant Drug Treatments
Fluvastatin
|
1 Participants
|
|
Concomitant Drug Treatments
Folic acid
|
4 Participants
|
|
Concomitant Drug Treatments
Folic acid/mecobalamin/pyridoxine hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Foraseq
|
1 Participants
|
|
Concomitant Drug Treatments
Formoterol
|
3 Participants
|
|
Concomitant Drug Treatments
Formoterol fumarate
|
1 Participants
|
|
Concomitant Drug Treatments
Fosinopril
|
3 Participants
|
|
Concomitant Drug Treatments
Fosinopril sodium
|
2 Participants
|
|
Concomitant Drug Treatments
Furosemide
|
3 Participants
|
|
Concomitant Drug Treatments
Gabapentin
|
2 Participants
|
|
Concomitant Drug Treatments
Galenic /fluticasone/salmeterol
|
2 Participants
|
|
Concomitant Drug Treatments
Galenic /salbutamol/guaifenesin
|
1 Participants
|
|
Concomitant Drug Treatments
General nutrients/minerals/vitamins
|
1 Participants
|
|
Concomitant Drug Treatments
Ginkgo biloba
|
1 Participants
|
|
Concomitant Drug Treatments
Ginkgo biloba extract
|
1 Participants
|
|
Concomitant Drug Treatments
Glibenclamide
|
1 Participants
|
|
Concomitant Drug Treatments
Gliclazide
|
12 Participants
|
|
Concomitant Drug Treatments
Glimepiride
|
13 Participants
|
|
Concomitant Drug Treatments
Glimepiride/metformin
|
2 Participants
|
|
Concomitant Drug Treatments
Glimepiride/metformin hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Glipizide
|
3 Participants
|
|
Concomitant Drug Treatments
Gliquidone
|
1 Participants
|
|
Concomitant Drug Treatments
Glucose
|
2 Participants
|
|
Concomitant Drug Treatments
Glyceryl trinitrate
|
4 Participants
|
|
Concomitant Drug Treatments
Guaifenesin
|
1 Participants
|
|
Concomitant Drug Treatments
Hedera helix
|
6 Participants
|
|
Concomitant Drug Treatments
Heparin-fraction
|
1 Participants
|
|
Concomitant Drug Treatments
Hepatitis B vaccine
|
1 Participants
|
|
Concomitant Drug Treatments
Herbal preparation
|
13 Participants
|
|
Concomitant Drug Treatments
Homeopatic preparation
|
9 Participants
|
|
Concomitant Drug Treatments
Hyaluronate sodium
|
2 Participants
|
|
Concomitant Drug Treatments
Hydrochlorothiazide
|
8 Participants
|
|
Concomitant Drug Treatments
Hydrotalcite
|
3 Participants
|
|
Concomitant Drug Treatments
Hydroxychloroquine
|
1 Participants
|
|
Concomitant Drug Treatments
Hydroxyzine
|
1 Participants
|
|
Concomitant Drug Treatments
Hydroxyzine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Hyoscine butylbromide
|
2 Participants
|
|
Concomitant Drug Treatments
Hyzaar
|
2 Participants
|
|
Concomitant Drug Treatments
I.v. solutions
|
2 Participants
|
|
Concomitant Drug Treatments
Ibuprofen
|
2 Participants
|
|
Concomitant Drug Treatments
Indapamide
|
2 Participants
|
|
Concomitant Drug Treatments
Indometacin
|
1 Participants
|
|
Concomitant Drug Treatments
Infliximab
|
1 Participants
|
|
Concomitant Drug Treatments
Inosine
|
1 Participants
|
|
Concomitant Drug Treatments
Insulin
|
10 Participants
|
|
Concomitant Drug Treatments
Insulin aspart
|
1 Participants
|
|
Concomitant Drug Treatments
Insulin glargine
|
2 Participants
|
|
Concomitant Drug Treatments
Insulin glulisine
|
1 Participants
|
|
Concomitant Drug Treatments
Insulin human
|
3 Participants
|
|
Concomitant Drug Treatments
Insulin human injection, isophane
|
2 Participants
|
|
Concomitant Drug Treatments
Ipratropium
|
1 Participants
|
|
Concomitant Drug Treatments
Ipratropium bromide
|
4 Participants
|
|
Concomitant Drug Treatments
Irbesartan
|
14 Participants
|
|
Concomitant Drug Treatments
Isoconazole nitrate
|
1 Participants
|
|
Concomitant Drug Treatments
Isosorbide dinitrate
|
3 Participants
|
|
Concomitant Drug Treatments
Isosorbide mononitrate
|
11 Participants
|
|
Concomitant Drug Treatments
Isotretinoin
|
1 Participants
|
|
Concomitant Drug Treatments
Ispaghula
|
1 Participants
|
|
Concomitant Drug Treatments
Ispaghula husk
|
1 Participants
|
|
Concomitant Drug Treatments
Itavastatin
|
8 Participants
|
|
Concomitant Drug Treatments
Itopride
|
1 Participants
|
|
Concomitant Drug Treatments
Itopride hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Itraconazole
|
3 Participants
|
|
Concomitant Drug Treatments
Karvea hct
|
3 Participants
|
|
Concomitant Drug Treatments
Kombipak II
|
1 Participants
|
|
Concomitant Drug Treatments
Lacidipine
|
1 Participants
|
|
Concomitant Drug Treatments
Lactitol
|
1 Participants
|
|
Concomitant Drug Treatments
Lactulose
|
3 Participants
|
|
Concomitant Drug Treatments
Lamivudine
|
3 Participants
|
|
Concomitant Drug Treatments
Lansoprazole
|
3 Participants
|
|
Concomitant Drug Treatments
Lekovit Ca
|
2 Participants
|
|
Concomitant Drug Treatments
Lenograstim
|
1 Participants
|
|
Concomitant Drug Treatments
Lercanidipine
|
1 Participants
|
|
Concomitant Drug Treatments
Lercanidipine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Levamlodipine besylate
|
2 Participants
|
|
Concomitant Drug Treatments
Levocarnitine
|
3 Participants
|
|
Concomitant Drug Treatments
Levocetirizine
|
1 Participants
|
|
Concomitant Drug Treatments
Levocetirizine dihydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Levocetirizine dihydrochloride/montelukast sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Levocloperastine fendizoate
|
2 Participants
|
|
Concomitant Drug Treatments
Levodropropizine
|
3 Participants
|
|
Concomitant Drug Treatments
Levofloxacin
|
14 Participants
|
|
Concomitant Drug Treatments
Levofloxacin hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Levosalbutamol hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Levosulpiride
|
6 Participants
|
|
Concomitant Drug Treatments
Levothyroxine sodium
|
4 Participants
|
|
Concomitant Drug Treatments
Lipase
|
1 Participants
|
|
Concomitant Drug Treatments
Lisinopril
|
2 Participants
|
|
Concomitant Drug Treatments
Lithium carbonate
|
1 Participants
|
|
Concomitant Drug Treatments
Loperamide
|
1 Participants
|
|
Concomitant Drug Treatments
Loratadine
|
2 Participants
|
|
Concomitant Drug Treatments
Lorazepam
|
3 Participants
|
|
Concomitant Drug Treatments
Losartan
|
9 Participants
|
|
Concomitant Drug Treatments
Losartan potassium
|
10 Participants
|
|
Concomitant Drug Treatments
Magnesium hydroxide
|
3 Participants
|
|
Concomitant Drug Treatments
Magnesium oxide
|
2 Participants
|
|
Concomitant Drug Treatments
Mecobalamin
|
4 Participants
|
|
Concomitant Drug Treatments
Medilac-S
|
3 Participants
|
|
Concomitant Drug Treatments
Mefloquine
|
1 Participants
|
|
Concomitant Drug Treatments
Megestrol acetate
|
1 Participants
|
|
Concomitant Drug Treatments
Meprobamate
|
1 Participants
|
|
Concomitant Drug Treatments
Meropenem
|
1 Participants
|
|
Concomitant Drug Treatments
Mesalazine
|
2 Participants
|
|
Concomitant Drug Treatments
Metformin
|
32 Participants
|
|
Concomitant Drug Treatments
Metformin hydrochloride
|
16 Participants
|
|
Concomitant Drug Treatments
Metformin hydrochloride/rosiglitazone
|
1 Participants
|
|
Concomitant Drug Treatments
Metformin hydrochloride/sitagliptin
|
1 Participants
|
|
Concomitant Drug Treatments
Methoxyphenamine
|
1 Participants
|
|
Concomitant Drug Treatments
Methylprednisolone
|
6 Participants
|
|
Concomitant Drug Treatments
Metoclopramide
|
2 Participants
|
|
Concomitant Drug Treatments
Metoclopramide hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Metoprolol
|
13 Participants
|
|
Concomitant Drug Treatments
Metoprolol succinate
|
3 Participants
|
|
Concomitant Drug Treatments
Metoprolol tartrate
|
6 Participants
|
|
Concomitant Drug Treatments
Metronidazole
|
1 Participants
|
|
Concomitant Drug Treatments
Milnacipran
|
1 Participants
|
|
Concomitant Drug Treatments
Milnacipran hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Mirtazapine
|
4 Participants
|
|
Concomitant Drug Treatments
Mobizox
|
1 Participants
|
|
Concomitant Drug Treatments
Molsidomine
|
2 Participants
|
|
Concomitant Drug Treatments
Mometasone
|
1 Participants
|
|
Concomitant Drug Treatments
Mometasone furoate
|
1 Participants
|
|
Concomitant Drug Treatments
Montelukast
|
3 Participants
|
|
Concomitant Drug Treatments
Montelukast sodium
|
4 Participants
|
|
Concomitant Drug Treatments
Mosapride
|
3 Participants
|
|
Concomitant Drug Treatments
Mosapride citrate
|
7 Participants
|
|
Concomitant Drug Treatments
Moxifloxacin
|
1 Participants
|
|
Concomitant Drug Treatments
Moxifloxacin hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Mucaine
|
1 Participants
|
|
Concomitant Drug Treatments
Multivitamins with minerals
|
3 Participants
|
|
Concomitant Drug Treatments
Multivitamins, plain
|
2 Participants
|
|
Concomitant Drug Treatments
Myprodol "rio ethicals"
|
2 Participants
|
|
Concomitant Drug Treatments
Myrin plus
|
1 Participants
|
|
Concomitant Drug Treatments
Myrtol
|
3 Participants
|
|
Concomitant Drug Treatments
Naltrexone
|
3 Participants
|
|
Concomitant Drug Treatments
Naproxen
|
1 Participants
|
|
Concomitant Drug Treatments
Nateglinide
|
4 Participants
|
|
Concomitant Drug Treatments
Nebivolol
|
1 Participants
|
|
Concomitant Drug Treatments
Nicorandil
|
5 Participants
|
|
Concomitant Drug Treatments
Nicotine
|
3 Participants
|
|
Concomitant Drug Treatments
Nicotinic acid
|
2 Participants
|
|
Concomitant Drug Treatments
Nifedipine
|
16 Participants
|
|
Concomitant Drug Treatments
Nimesulide/paracetamol
|
1 Participants
|
|
Concomitant Drug Treatments
Nimodipine
|
2 Participants
|
|
Concomitant Drug Treatments
Nisoldipine
|
1 Participants
|
|
Concomitant Drug Treatments
Nitrendipine
|
1 Participants
|
|
Concomitant Drug Treatments
Nizatidine
|
2 Participants
|
|
Concomitant Drug Treatments
Ofloxacin
|
2 Participants
|
|
Concomitant Drug Treatments
Olanzapine
|
2 Participants
|
|
Concomitant Drug Treatments
Olmesartan
|
6 Participants
|
|
Concomitant Drug Treatments
Olmesartan medoxomil
|
1 Participants
|
|
Concomitant Drug Treatments
Omega-3 marine triglycerides
|
2 Participants
|
|
Concomitant Drug Treatments
Omega-3 triglycerides
|
3 Participants
|
|
Concomitant Drug Treatments
Omeprazole
|
9 Participants
|
|
Concomitant Drug Treatments
Ondansetron
|
2 Participants
|
|
Concomitant Drug Treatments
Ondansetron hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Orlistat
|
4 Participants
|
|
Concomitant Drug Treatments
Oxazepam
|
2 Participants
|
|
Concomitant Drug Treatments
Oxcarbazepine
|
1 Participants
|
|
Concomitant Drug Treatments
Oxycodone
|
1 Participants
|
|
Concomitant Drug Treatments
Oxycodone hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Palonosetron hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Pantoprazole
|
7 Participants
|
|
Concomitant Drug Treatments
Pantoprazole sodium
|
10 Participants
|
|
Concomitant Drug Treatments
Paracetamol
|
9 Participants
|
|
Concomitant Drug Treatments
Paroxetine
|
3 Participants
|
|
Concomitant Drug Treatments
Paroxetine hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Pentamycin
|
1 Participants
|
|
Concomitant Drug Treatments
Perindopril
|
8 Participants
|
|
Concomitant Drug Treatments
Phenylephrine/triprolidine
|
1 Participants
|
|
Concomitant Drug Treatments
Phenytoin sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Phosphatidyl choline
|
1 Participants
|
|
Concomitant Drug Treatments
Phytomenadione
|
1 Participants
|
|
Concomitant Drug Treatments
Pinaverium bromide
|
1 Participants
|
|
Concomitant Drug Treatments
Pioglitazone
|
4 Participants
|
|
Concomitant Drug Treatments
Pioglitazone hydrochloride
|
4 Participants
|
|
Concomitant Drug Treatments
Platelets, human blood
|
1 Participants
|
|
Concomitant Drug Treatments
Pneumococcal vaccine
|
1 Participants
|
|
Concomitant Drug Treatments
Polycarbophil calcium
|
2 Participants
|
|
Concomitant Drug Treatments
Pramipexole
|
2 Participants
|
|
Concomitant Drug Treatments
Pranlukast hydrate
|
1 Participants
|
|
Concomitant Drug Treatments
Pravastatin
|
8 Participants
|
|
Concomitant Drug Treatments
Pravastatin sodium
|
5 Participants
|
|
Concomitant Drug Treatments
Prednicarbate
|
1 Participants
|
|
Concomitant Drug Treatments
Prednisolone
|
5 Participants
|
|
Concomitant Drug Treatments
Pregabalin
|
3 Participants
|
|
Concomitant Drug Treatments
Procaterol
|
1 Participants
|
|
Concomitant Drug Treatments
Promethazine
|
1 Participants
|
|
Concomitant Drug Treatments
Pronase
|
2 Participants
|
|
Concomitant Drug Treatments
Propranolol
|
2 Participants
|
|
Concomitant Drug Treatments
Propranolol hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Propylthiouracil
|
1 Participants
|
|
Concomitant Drug Treatments
Pseudoephedrine hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Pyridostigmine bromide
|
1 Participants
|
|
Concomitant Drug Treatments
Pyridoxine hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Quetiapine fumarate
|
2 Participants
|
|
Concomitant Drug Treatments
Rabeprazole
|
9 Participants
|
|
Concomitant Drug Treatments
Rabeprazole sodium
|
2 Participants
|
|
Concomitant Drug Treatments
Raloxifene
|
1 Participants
|
|
Concomitant Drug Treatments
Ramipril
|
7 Participants
|
|
Concomitant Drug Treatments
Ranitidine
|
4 Participants
|
|
Concomitant Drug Treatments
Ranitidine hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Rebamipide
|
12 Participants
|
|
Concomitant Drug Treatments
Repaglinide
|
3 Participants
|
|
Concomitant Drug Treatments
Rino ebastel
|
1 Participants
|
|
Concomitant Drug Treatments
Riopan plus
|
1 Participants
|
|
Concomitant Drug Treatments
Risedronic acid
|
1 Participants
|
|
Concomitant Drug Treatments
Risperidone
|
3 Participants
|
|
Concomitant Drug Treatments
Rosiglitazone maleate
|
2 Participants
|
|
Concomitant Drug Treatments
Rosuvastatin
|
24 Participants
|
|
Concomitant Drug Treatments
Rosuvastatin calcium
|
1 Participants
|
|
Concomitant Drug Treatments
Roxithromycin
|
2 Participants
|
|
Concomitant Drug Treatments
Salbutamol
|
9 Participants
|
|
Concomitant Drug Treatments
Salbutamol sulfate
|
1 Participants
|
|
Concomitant Drug Treatments
Salmeterol
|
2 Participants
|
|
Concomitant Drug Treatments
Salmeterol xinafoate
|
6 Participants
|
|
Concomitant Drug Treatments
Salvia miltiorrhiza
|
1 Participants
|
|
Concomitant Drug Treatments
Sarpogrelate
|
1 Participants
|
|
Concomitant Drug Treatments
Sarpogrelate hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Selective beta-2-adrenoreceptor agonists
|
1 Participants
|
|
Concomitant Drug Treatments
Selegiline hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Seretide "allen & hanburys ltd"
|
2 Participants
|
|
Concomitant Drug Treatments
Seretide mite
|
17 Participants
|
|
Concomitant Drug Treatments
Sertraline
|
2 Participants
|
|
Concomitant Drug Treatments
Sibutramine
|
3 Participants
|
|
Concomitant Drug Treatments
Sibutramine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Sildenafil citrate
|
2 Participants
|
|
Concomitant Drug Treatments
Silymarin
|
2 Participants
|
|
Concomitant Drug Treatments
Simeco
|
1 Participants
|
|
Concomitant Drug Treatments
Simvastatin
|
21 Participants
|
|
Concomitant Drug Treatments
Sinemet
|
1 Participants
|
|
Concomitant Drug Treatments
Sirolin retard
|
2 Participants
|
|
Concomitant Drug Treatments
Sitagliptin
|
6 Participants
|
|
Concomitant Drug Treatments
Sodium chloride
|
1 Participants
|
|
Concomitant Drug Treatments
Sotalol hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Spedifen
|
1 Participants
|
|
Concomitant Drug Treatments
Spirapril hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Spironolactone
|
2 Participants
|
|
Concomitant Drug Treatments
Spironolactone / torasemide
|
1 Participants
|
|
Concomitant Drug Treatments
Streptomycin
|
1 Participants
|
|
Concomitant Drug Treatments
Sucralfate
|
1 Participants
|
|
Concomitant Drug Treatments
Sulglicotide
|
3 Participants
|
|
Concomitant Drug Treatments
Sulodexide
|
1 Participants
|
|
Concomitant Drug Treatments
Symbicort turbuhaler "draco"
|
11 Participants
|
|
Concomitant Drug Treatments
Tadalafil
|
1 Participants
|
|
Concomitant Drug Treatments
Tamsulosin
|
5 Participants
|
|
Concomitant Drug Treatments
Tamsulosin hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Tazobactam sodium
|
1 Participants
|
|
Concomitant Drug Treatments
Telmisartan
|
17 Participants
|
|
Concomitant Drug Treatments
Terazosin
|
1 Participants
|
|
Concomitant Drug Treatments
Terazosin hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Terbinafine hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Terbutaline
|
3 Participants
|
|
Concomitant Drug Treatments
Terbutaline sulfate
|
1 Participants
|
|
Concomitant Drug Treatments
Testosterone undecanoate
|
1 Participants
|
|
Concomitant Drug Treatments
Theophylline
|
18 Participants
|
|
Concomitant Drug Treatments
Thiamazole
|
2 Participants
|
|
Concomitant Drug Treatments
Thioctic acid
|
1 Participants
|
|
Concomitant Drug Treatments
Throat preparations
|
1 Participants
|
|
Concomitant Drug Treatments
Tianeptine
|
4 Participants
|
|
Concomitant Drug Treatments
Ticlopidine
|
1 Participants
|
|
Concomitant Drug Treatments
Tiotropium
|
10 Participants
|
|
Concomitant Drug Treatments
Tiotropium bromide
|
3 Participants
|
|
Concomitant Drug Treatments
Tiotropium bromide/formoterol fumarate
|
1 Participants
|
|
Concomitant Drug Treatments
Tiropramide hydrochloride
|
3 Participants
|
|
Concomitant Drug Treatments
Tocopherol
|
1 Participants
|
|
Concomitant Drug Treatments
Tolterodine
|
1 Participants
|
|
Concomitant Drug Treatments
Tramadol
|
1 Participants
|
|
Concomitant Drug Treatments
Tramadol hydrochloride
|
1 Participants
|
|
Concomitant Drug Treatments
Tranexamic acid
|
2 Participants
|
|
Concomitant Drug Treatments
Trazodone
|
1 Participants
|
|
Concomitant Drug Treatments
Triaprin
|
1 Participants
|
|
Concomitant Drug Treatments
Triazolam
|
1 Participants
|
|
Concomitant Drug Treatments
Triflusal
|
1 Participants
|
|
Concomitant Drug Treatments
Trihexyphenidyl
|
1 Participants
|
|
Concomitant Drug Treatments
Trimebutine
|
1 Participants
|
|
Concomitant Drug Treatments
Trimebutine maleate
|
1 Participants
|
|
Concomitant Drug Treatments
Trimetazidine
|
4 Participants
|
|
Concomitant Drug Treatments
Trimetazidine hydrochloride
|
2 Participants
|
|
Concomitant Drug Treatments
Tromcardin
|
1 Participants
|
|
Concomitant Drug Treatments
Udenafil
|
2 Participants
|
|
Concomitant Drug Treatments
Ultracet
|
3 Participants
|
|
Concomitant Drug Treatments
Ursodeoxycholic acid
|
8 Participants
|
|
Concomitant Drug Treatments
Valproate semisodium
|
1 Participants
|
|
Concomitant Drug Treatments
Valsartan
|
10 Participants
|
|
Concomitant Drug Treatments
Varidase
|
1 Participants
|
|
Concomitant Drug Treatments
Verapamil
|
1 Participants
|
|
Concomitant Drug Treatments
Vildagliptin
|
1 Participants
|
|
Concomitant Drug Treatments
Vitamin B
|
1 Participants
|
|
Concomitant Drug Treatments
Vitamins
|
1 Participants
|
|
Concomitant Drug Treatments
Vitamins with minerals
|
1 Participants
|
|
Concomitant Drug Treatments
Vitamins, other combinations
|
1 Participants
|
|
Concomitant Drug Treatments
Voglibose
|
3 Participants
|
|
Concomitant Drug Treatments
Warfarin
|
7 Participants
|
|
Concomitant Drug Treatments
Yeast
|
1 Participants
|
|
Concomitant Drug Treatments
Zevit
|
2 Participants
|
|
Concomitant Drug Treatments
Zinc
|
1 Participants
|
|
Concomitant Drug Treatments
Zoledronic acid
|
2 Participants
|
|
Concomitant Drug Treatments
Zolpidem
|
10 Participants
|
|
Concomitant Drug Treatments
Zolpidem tartrate
|
6 Participants
|
Adverse Events
Varenicline
Serious events: 11 serious events
Other events: 379 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=1373 participants at risk
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchiectasis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Haemorrhagic fever
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Acute stress disorder
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Varenicline
n=1373 participants at risk
Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
|
|---|---|
|
Psychiatric disorders
Emotional disorder
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Euphoric mood
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Impatience
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
3.0%
41/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Listless
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Restlessness
|
0.51%
7/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.36%
5/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Albuminuria
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Polyuria
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal pain
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Bradyphrenia
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.51%
7/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.80%
11/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.44%
6/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.87%
12/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.36%
5/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
6/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.58%
8/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
156/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Periodontitis
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Regurgitation
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
12/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.80%
11/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hunger
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.44%
6/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media chronic
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.51%
7/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
1.2%
17/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.73%
10/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
3.1%
42/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.51%
7/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
1.5%
20/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypersomnia
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Poor quality sleep
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.80%
11/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
2.0%
28/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Aggression
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.51%
7/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety disorder
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.29%
4/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.15%
2/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Essential hypertension
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.07%
1/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.22%
3/1373
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER