Smoking Cessation
Conditions
Keywords
Observational non-interventional trial
Brief summary
The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice.
Detailed description
Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.
Interventions
DRUGvarenicline
Champix will be prescribed as per usual practice and at the sole discretion of the physician
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion
Exclusion criteria
* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Smoking Abstinence at Week 12 | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit | Last observed study visit (Week 12 or early termination [ET]) | 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. |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 3 through Week 11 | 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. |
| CO Level at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | 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. |
| Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Dose of Varenicline | Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET) | — |
| Median Duration of Treatment of Varenicline | Baseline through last observed study visit (Week 12 or ET) | The duration was defined as the total number of dosing days from first to last day of each study treatment. |
| Concomitant Drug Treatments | Baseline through Last observed study visit (Week 12 or ET) | — |
| Varenicline Prescription Status | After last observed study visit (Week 12 or ET) | 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'. |
Countries
China, India, Philippines, South Korea
Participant flow
Pre-assignment details
A total of 1429 participants were screened for this study and 1377 participants were assigned to the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,373 |
| Total | 1,373 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Death | 1 |
| Overall Study | Enrolled but not treated | 4 |
| Overall Study | Lack of Efficacy | 58 |
| Overall Study | Lost to Follow-up | 76 |
| Overall Study | Other | 25 |
| Overall Study | Participants not willing to participate | 158 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Continuous | 45.2 Years STANDARD_DEVIATION 12.5 |
| Average number of cigarettes smoked per day in the previous 7 day period at baseline | 20.0 cigarettes |
| Cardiovascular risk factors Documented Ankle Brachial Index (ABI) <0.9 | 3 participants |
| Cardiovascular risk factors Family history of Cardiovascular disease or stroke | 111 participants |
| Cardiovascular risk factors History of microalbuminuria | 9 participants |
| Cardiovascular risk factors Left ventricular hypertrophy | 13 participants |
| Cardiovascular risk factors Unspecified | 13 participants |
| Exhaled Carbon monoxide (CO) level | 14.20 parts per million (ppm) STANDARD_DEVIATION 7.69 |
| Fagerstrom Test of Nicotine Dependence (FTND) | 5.50 Scores on a scale STANDARD_DEVIATION 2.43 |
| Family history of mental illness Alcohol abuse (n=122) | 12 participants |
| Family history of mental illness Cerebral apoplexy (n=1) | 1 participants |
| Family history of mental illness Dementia (n=120) | 2 participants |
| Family history of mental illness Depression (Chronic or recurrent) (n=119) | 2 participants |
| Family history of mental illness Dissociative disorder (n=1) | 1 participants |
| Family history of mental illness Major depression (n=120) | 1 participants |
| Family history of mental illness Mental disorder (n=1) | 1 participants |
| Family history of mental illness Nicotine addiction (n=8) | 8 participants |
| Family history of mental illness Parkinson's disease (n=1) | 1 participants |
| Family history of mental illness Schizophrenia (n=120) | 4 participants |
| Health care utilization: Employment status Full-time employed | 1016 participants |
| Health care utilization: Employment status Not employed | 235 participants |
| Health care utilization: Employment status Part-time employed | 15 participants |
| Healthcare utilization status: Reimbursement type No Insurance | 276 participants |
| Healthcare utilization status: Reimbursement type Other unspecified | 23 participants |
| Healthcare utilization status: Reimbursement type Private Insurance | 111 participants |
| Healthcare utilization status: Reimbursement type Public Insurance | 877 participants |
| Medical History Abdominal discomfort | 1 participants |
| Medical History Abdominal pain upper | 1 participants |
| Medical History Acne | 1 participants |
| Medical History Acute lymphocytic leukaemia | 1 participants |
| Medical History Acute myocardial infarction | 2 participants |
| Medical History Alcohol abuse | 46 participants |
| Medical History Alcoholic | 1 participants |
| Medical History Alcoholic liver disease | 1 participants |
| Medical History Alopecia areata | 1 participants |
| Medical History Angina pectoris | 18 participants |
| Medical History Ankylosing spondylitis | 1 participants |
| Medical History Aortic valve replacement | 1 participants |
| Medical History Appendicitis | 1 participants |
| Medical History Arrhythmia | 3 participants |
| Medical History Arteriosclerosis | 2 participants |
| Medical History Arteriosclerosis coronary artery | 1 participants |
| Medical History Arthritis | 1 participants |
| Medical History Asthma | 65 participants |
| Medical History Atrial fibrillation | 5 participants |
| Medical History Back pain | 1 participants |
| Medical History Basedow's disease | 2 participants |
| Medical History Behcet's syndrome | 1 participants |
| Medical History Benign lung neoplasm | 1 participants |
| Medical History Benign prostatic hyperplasia | 9 participants |
| Medical History Bipolar disorder | 2 participants |
| Medical History Bladder irritation | 1 participants |
| Medical History Blindness unilateral | 1 participants |
| Medical History Blood cholesterol increased | 1 participants |
| Medical History Blood viscosity increased | 1 participants |
| Medical History Body tinea | 1 participants |
| Medical History Brain neoplasm | 1 participants |
| Medical History Bronchiectasis | 5 participants |
| Medical History Bronchitis | 15 participants |
| Medical History Bronchitis chronic | 19 participants |
| Medical History Bundle branch block right | 1 participants |
| Medical History Calcium deficiency | 1 participants |
| Medical History Cardiac failure | 1 participants |
| Medical History Cardiac failure congestive | 2 participants |
| Medical History Cardiac valve disease | 1 participants |
| Medical History Carotid artery occlusion | 1 participants |
| Medical History Carotid artery stenosis | 3 participants |
| Medical History Cerebral arteriosclerosis | 1 participants |
| Medical History Cerebral infarction | 4 participants |
| Medical History Cerebral ischaemia | 1 participants |
| Medical History Cerebrovascular accident | 21 participants |
| Medical History Cervix carcinoma | 1 participants |
| Medical History Chest pain | 2 participants |
| Medical History Cholecystitis | 2 participants |
| Medical History Cholelithiasis | 1 participants |
| Medical History Chronic hepatitis | 2 participants |
| Medical History Chronic obstructive pulmonary disease | 116 participants |
| Medical History Chronic sinusitis | 1 participants |
| Medical History Colitis | 1 participants |
| Medical History Colonic polyp | 3 participants |
| Medical History Congestive cardiomyopathy | 1 participants |
| Medical History Constipation | 3 participants |
| Medical History Coronary artery disease | 72 participants |
| Medical History Coronary artery stenosis | 1 participants |
| Medical History Cor pulmonale chronic | 1 participants |
| Medical History Cough | 6 participants |
| Medical History Crohn's disease | 1 participants |
| Medical History Cystitis | 1 participants |
| Medical History Dementia | 1 participants |
| Medical History Depressed mood | 1 participants |
| Medical History Depression | 8 participants |
| Medical History Dermatitis contact | 1 participants |
| Medical History Diabetes mellitus | 132 participants |
| Medical History Diverticulum intestinal | 1 participants |
| Medical History Dizziness | 2 participants |
| Medical History Duodenal ulcer | 6 participants |
| Medical History Duodenitis | 1 participants |
| Medical History Dyslipidaemia | 167 participants |
| Medical History Dyspepsia | 5 participants |
| Medical History Dyspnoea | 3 participants |
| Medical History Dysthymic disorder | 1 participants |
| Medical History Emphysema | 7 participants |
| Medical History Epistaxis | 1 participants |
| Medical History Erectile dysfunction | 2 participants |
| Medical History Extranodal marginal zone B-cell lymphoma | 1 participants |
| Medical History Fatigue | 3 participants |
| Medical History Gastric adenoma | 1 participants |
| Medical History Gastric cancer | 1 participants |
| Medical History Gastric haemorrhage | 1 participants |
| Medical History Gastric ulcer | 6 participants |
| Medical History Gastritis | 53 participants |
| Medical History Gastritis atrophic | 4 participants |
| Medical History Gastritis erosive | 4 participants |
| Medical History Gastrooesophageal reflux disease | 11 participants |
| Medical History Generalised anxiety disorder | 11 participants |
| Medical History Goitre | 1 participants |
| Medical History Gout | 1 participants |
| Medical History Haemoptysis | 3 participants |
| Medical History Haemorrhoid operation | 1 participants |
| Medical History Haemorrhoids | 1 participants |
| Medical History Headache | 6 participants |
| Medical History Head and neck cancer | 2 participants |
| Medical History Hearing impaired | 1 participants |
| Medical History Helicobacter infection | 1 participants |
| Medical History Hepatic cyst | 1 participants |
| Medical History Hepatic neoplasm malignant | 1 participants |
| Medical History Hepatic steatosis | 12 participants |
| Medical History Hepatitis | 2 participants |
| Medical History Hepatitis alcoholic | 1 participants |
| Medical History Hepatitis B | 3 participants |
| Medical History Hepatitis B virus test | 1 participants |
| Medical History Histiocytosis haematophagic | 1 participants |
| Medical History HIV test positive | 1 participants |
| Medical History Hypercholesterolaemia | 2 participants |
| Medical History Hyperhomocysteinaemia | 1 participants |
| Medical History Hyperlipidaemia | 19 participants |
| Medical History Hypertension | 229 participants |
| Medical History Hyperthyroidism | 3 participants |
| Medical History Hyperuricaemia | 5 participants |
| Medical History Hypothyroidism | 5 participants |
| Medical History Idiopathic pulmonary fibrosis | 1 participants |
| Medical History Impaired fasting glucose | 1 participants |
| Medical History Insomnia | 5 participants |
| Medical History Interstitial lung disease | 3 participants |
| Medical History Intervertebral disc disorder | 1 participants |
| Medical History Intestinal polyp | 1 participants |
| Medical History Iron deficiency | 1 participants |
| Medical History Irritable bowel syndrome | 2 participants |
| Medical History Laryngeal cancer | 1 participants |
| Medical History Left ventricular hypertrophy | 1 participants |
| Medical History Leiomyosarcoma | 1 participants |
| Medical History Liver function test abnormal | 1 participants |
| Medical History Lower respiratory tract infection | 1 participants |
| Medical History Lung abscess | 1 participants |
| Medical History Lung neoplasm | 9 participants |
| Medical History Lung neoplasm malignant | 8 participants |
| Medical History Major depression | 17 participants |
| Medical History Malaise | 1 participants |
| Medical History Meniscus lesion | 1 participants |
| Medical History Mitral valve calcification | 1 participants |
| Medical History Myasthenia gravis | 1 participants |
| Medical History Myocardial infarction | 1 participants |
| Medical History Myocardial ischaemia | 1 participants |
| Medical History Nasopharyngitis | 1 participants |
| Medical History Nausea | 1 participants |
| Medical History Neck pain | 1 participants |
| Medical History Nephrolithiasis | 1 participants |
| Medical History Neuropathy peripheral | 1 participants |
| Medical History Obesity | 7 participants |
| Medical History Obsessive-compulsive disorder | 1 participants |
| Medical History Oesophagitis | 2 participants |
| Medical History Onychomycosis | 1 participants |
| Medical History Organic erectile dysfunction | 1 participants |
| Medical History Osteoarthritis | 2 participants |
| Medical History Osteopenia | 1 participants |
| Medical History Osteoporosis | 4 participants |
| Medical History Pain | 1 participants |
| Medical History Pancreatitis | 2 participants |
| Medical History Pancreatitis chronic | 1 participants |
| Medical History Panic attack | 5 participants |
| Medical History Panic disorder | 6 participants |
| Medical History Parkinson's disease | 1 participants |
| Medical History Peptic ulcer | 50 participants |
| Medical History Periodontitis | 1 participants |
| Medical History Peripheral vascular disorder | 2 participants |
| Medical History Personality disorder | 5 participants |
| Medical History Pharyngitis | 12 participants |
| Medical History Pleural effusion | 1 participants |
| Medical History Pneumonia | 7 participants |
| Medical History Pneumothorax | 1 participants |
| Medical History Prinzmetal angina | 2 participants |
| Medical History Prostate cancer | 1 participants |
| Medical History Proteinuria | 1 participants |
| Medical History Pruritus | 1 participants |
| Medical History Psychotic disorder | 1 participants |
| Medical History Pulmonary bulla | 1 participants |
| Medical History Pulmonary embolism | 1 participants |
| Medical History Pulmonary mass | 3 participants |
| Medical History Pulmonary tuberculosis | 8 participants |
| Medical History Pyelonephritis acute | 1 participants |
| Medical History Rectal cancer | 2 participants |
| Medical History Reflux oesophagitis | 11 participants |
| Medical History Renal cancer | 2 participants |
| Medical History Renal cell carcinoma | 1 participants |
| Medical History Renal failure chronic | 2 participants |
| Medical History Renal neoplasm | 1 participants |
| Medical History Respiratory disorder | 2 participants |
| Medical History Rheumatoid arthritis | 4 participants |
| Medical History Rhinitis | 7 participants |
| Medical History Rhinitis allergic | 7 participants |
| Medical History Sarcoidosis | 1 participants |
| Medical History Schizoaffective disorder | 1 participants |
| Medical History Schizophrenia | 3 participants |
| Medical History Sedation | 1 participants |
| Medical History Sinus tachycardia | 1 participants |
| Medical History Sleep apnoea syndrome | 5 participants |
| Medical History Sleep disorder | 4 participants |
| Medical History Snoring | 1 participants |
| Medical History Social phobia | 2 participants |
| Medical History Substance abuse | 14 participants |
| Medical History Thromboangiitis obliterans | 2 participants |
| Medical History Thyroid cyst | 1 participants |
| Medical History Tinea pedis | 2 participants |
| Medical History Tonsillitis | 1 participants |
| Medical History Transient ischaemic attack | 2 participants |
| Medical History Tuberculosis | 3 participants |
| Medical History Tuberculosis gastrointestinal | 1 participants |
| Medical History Tuberculous pleurisy | 2 participants |
| Medical History Upper respiratory tract infection | 2 participants |
| Medical History Urticaria | 1 participants |
| Medical History Vasculitis | 1 participants |
| Medical History Ventricular extrasystoles | 1 participants |
| Medical History Visual impairment | 1 participants |
| Nondrug treatments / procedures for primary diagnosis Other unspecified | 1 participants |
| Nondrug treatments / procedures for primary diagnosis Quit Smoking Clinic | 190 participants |
| Nondrug treatments / procedures for primary diagnosis Smoking Cessation Counseling | 661 participants |
| Participant social status : Current Living Situation Living alone | 45 participants |
| Participant social status : Current Living Situation Living in institution | 1 participants |
| Participant social status : Current Living Situation Living in residential treatment center | 1 participants |
| Participant social status : Current Living Situation Living with a spouse or significant other | 1002 participants |
| Participant social status : Current Living Situation Living with other family member(s) or roommate(s) | 193 participants |
| Participant social status : Current Living Situation Other unspecified | 1 participants |
| Participant social status : Current Marital Status Cohabitating | 1 participants |
| Participant social status : Current Marital Status Divorced | 13 participants |
| Participant social status : Current Marital Status Married | 1124 participants |
| Participant social status : Current Marital Status Never Married | 104 participants |
| Participant social status : Current Marital Status Separated | 4 participants |
| Participant social status : Current Marital Status Widowed | 12 participants |
| Prior Drug Treatment Acamprosate | 2 participants |
| Prior Drug Treatment Acarbose | 14 participants |
| Prior Drug Treatment Aceclofenac | 1 participants |
| Prior Drug Treatment Acetylcarnitine | 1 participants |
| Prior Drug Treatment Acetylcysteine | 11 participants |
| Prior Drug Treatment Acetylsalicylic acid | 99 participants |
| Prior Drug Treatment Acetylsalicylic acid/atorvastatin/ramipril | 1 participants |
| Prior Drug Treatment Acetylsalicylic acid/clopidogrel | 1 participants |
| Prior Drug Treatment Adenine/biphenyldimethyldicarboxylate/vitamins | 1 participants |
| Prior Drug Treatment Alfuzosin | 1 participants |
| Prior Drug Treatment Allopurinol | 2 participants |
| Prior Drug Treatment All other therapeutic products | 6 participants |
| Prior Drug Treatment Almagate | 4 participants |
| Prior Drug Treatment Alprazolam | 6 participants |
| Prior Drug Treatment Ambroxol | 4 participants |
| Prior Drug Treatment Ambroxol acefyllinate | 1 participants |
| Prior Drug Treatment Ambroxol hydrochloride | 8 participants |
| Prior Drug Treatment Aminophylline | 2 participants |
| Prior Drug Treatment Amisulpride | 1 participants |
| Prior Drug Treatment Amitriptyline hydrochloride | 2 participants |
| Prior Drug Treatment Amlodipine | 17 participants |
| Prior Drug Treatment Amlodipine besilate | 17 participants |
| Prior Drug Treatment Amlodipine besilate/atorvastatin calcium | 2 participants |
| Prior Drug Treatment Amlodipine besylate/valsartan | 2 participants |
| Prior Drug Treatment Amlodipine camsilate | 2 participants |
| Prior Drug Treatment Amlodipine maleate | 2 participants |
| Prior Drug Treatment Amlodipine orotate | 2 participants |
| Prior Drug Treatment Amlodipine/valsartan | 3 participants |
| Prior Drug Treatment Amoxicillin | 6 participants |
| Prior Drug Treatment Amoxicillin sodium | 1 participants |
| Prior Drug Treatment Antisterone | 2 participants |
| Prior Drug Treatment Aripiprazole | 1 participants |
| Prior Drug Treatment Aronamin gold | 1 participants |
| Prior Drug Treatment Arotinolol hydrochloride | 1 participants |
| Prior Drug Treatment Artemisia asiatica | 1 participants |
| Prior Drug Treatment Artemisia asiatica/ethanol | 1 participants |
| Prior Drug Treatment Asmeton | 9 participants |
| Prior Drug Treatment Atenolol | 2 participants |
| Prior Drug Treatment Atorvastatin | 44 participants |
| Prior Drug Treatment Atorvastatin calcium | 9 participants |
| Prior Drug Treatment Azathioprine | 2 participants |
| Prior Drug Treatment Azelastine | 2 participants |
| Prior Drug Treatment Azelastine hydrochloride | 2 participants |
| Prior Drug Treatment Azithromycin | 3 participants |
| Prior Drug Treatment Aztreonam | 1 participants |
| Prior Drug Treatment Bambuterol hydrochloride | 1 participants |
| Prior Drug Treatment Becosules syrup | 2 participants |
| Prior Drug Treatment Becosym forte | 1 participants |
| Prior Drug Treatment Becotal | 1 participants |
| Prior Drug Treatment Benazepril | 1 participants |
| Prior Drug Treatment Benazepril hydrochloride | 2 participants |
| Prior Drug Treatment Benproperine | 1 participants |
| Prior Drug Treatment Benproperine phosphate | 1 participants |
| Prior Drug Treatment Bepotastine besilate | 2 participants |
| Prior Drug Treatment Beraprost | 1 participants |
| Prior Drug Treatment Betahistine | 1 participants |
| Prior Drug Treatment Bevantolol | 1 participants |
| Prior Drug Treatment Biphenyl dimethyl dicarboxylate/garlic | 1 participants |
| Prior Drug Treatment Biselect | 1 participants |
| Prior Drug Treatment Bismuth subcitrate tripotassium | 1 participants |
| Prior Drug Treatment Bismuth subcitrate tripotassium/ranitidine HCl | 2 participants |
| Prior Drug Treatment Bisoprolol | 6 participants |
| Prior Drug Treatment Bisoprolol fumarate | 12 participants |
| Prior Drug Treatment B-komplex leciva | 1 participants |
| Prior Drug Treatment Borneol/notoginseng/salvia miltiorrhiza | 1 participants |
| Prior Drug Treatment Bromelains/dehydrocholic/pancreatin/simeticone | 1 participants |
| Prior Drug Treatment Broncho-vaxom | 2 participants |
| Prior Drug Treatment Budesonide | 2 participants |
| Prior Drug Treatment Bupropion | 1 participants |
| Prior Drug Treatment Bupropion hydrochloride | 1 participants |
| Prior Drug Treatment Buspiron | 1 participants |
| Prior Drug Treatment Buspirone | 1 participants |
| Prior Drug Treatment Calcium chloride | 1 participants |
| Prior Drug Treatment Calcium citrate/colecalciferol | 1 participants |
| Prior Drug Treatment Calcium lactate | 1 participants |
| Prior Drug Treatment Candesartan | 6 participants |
| Prior Drug Treatment Candesartan cilexetil | 2 participants |
| Prior Drug Treatment Carbazochrome | 1 participants |
| Prior Drug Treatment Cardiovascular system drugs | 1 participants |
| Prior Drug Treatment Carvedilol | 7 participants |
| Prior Drug Treatment Cefaclor | 5 participants |
| Prior Drug Treatment Cefoperazone sodium | 2 participants |
| Prior Drug Treatment Cefpodoxime | 1 participants |
| Prior Drug Treatment Cefpodoxime proxetil | 1 participants |
| Prior Drug Treatment Cefradine | 1 participants |
| Prior Drug Treatment Ceftriaxone sodium | 1 participants |
| Prior Drug Treatment Cefuroxime | 3 participants |
| Prior Drug Treatment Cefuroxime sodium | 1 participants |
| Prior Drug Treatment Cephalosporins and related substances | 2 participants |
| Prior Drug Treatment Cetirizine | 1 participants |
| Prior Drug Treatment Chlormadinone acetate | 1 participants |
| Prior Drug Treatment Choline alfoscerate | 5 participants |
| Prior Drug Treatment Chondroitin/glucosamine | 1 participants |
| Prior Drug Treatment Cilazapril | 2 participants |
| Prior Drug Treatment Cilnidipine | 6 participants |
| Prior Drug Treatment Cilostazol | 3 participants |
| Prior Drug Treatment Cimetidine | 1 participants |
| Prior Drug Treatment Ciprofloxacin | 2 participants |
| Prior Drug Treatment Citalopram | 1 participants |
| Prior Drug Treatment Clarithromycin | 5 participants |
| Prior Drug Treatment Clobazam | 1 participants |
| Prior Drug Treatment Clonazepam | 3 participants |
| Prior Drug Treatment Clopidogrel | 19 participants |
| Prior Drug Treatment Clopidogrel sulfate | 16 participants |
| Prior Drug Treatment Co-diovan | 2 participants |
| Prior Drug Treatment Colchicine | 2 participants |
| Prior Drug Treatment Cordalin /old form | 1 participants |
| Prior Drug Treatment Cough syrup | 1 participants |
| Prior Drug Treatment Dexamethasone | 1 participants |
| Prior Drug Treatment Dexamethasone/neomycin sulfate/polymyxin B sulfate | 1 participants |
| Prior Drug Treatment Diacerein | 1 participants |
| Prior Drug Treatment Diazepam | 2 participants |
| Prior Drug Treatment Diclofenac | 1 participants |
| Prior Drug Treatment Digoxin | 2 participants |
| Prior Drug Treatment Dihydrocodeine bitartrate | 2 participants |
| Prior Drug Treatment Diltiazem | 6 participants |
| Prior Drug Treatment Diltiazem hydrochloride | 1 participants |
| Prior Drug Treatment Dimenhydrinate | 1 participants |
| Prior Drug Treatment Diprophylline | 1 participants |
| Prior Drug Treatment Disulfiram | 1 participants |
| Prior Drug Treatment Domperidone | 4 participants |
| Prior Drug Treatment Donepezil | 1 participants |
| Prior Drug Treatment Doxazosin mesilate | 1 participants |
| Prior Drug Treatment Doxofylline | 14 participants |
| Prior Drug Treatment Drug, unspecified | 3 participants |
| Prior Drug Treatment Duloxetine hydrochloride | 1 participants |
| Prior Drug Treatment Ecabet monosodium | 1 participants |
| Prior Drug Treatment Efavirenz/emtricitabine/tenofovir | 1 participants |
| Prior Drug Treatment Efonidipine | 1 participants |
| Prior Drug Treatment Enalapril | 2 participants |
| Prior Drug Treatment Enalapril maleate | 1 participants |
| Prior Drug Treatment Enzymes | 1 participants |
| Prior Drug Treatment Epoprostenol | 1 participants |
| Prior Drug Treatment Eprosartan | 2 participants |
| Prior Drug Treatment Eprosartan mesilate | 1 participants |
| Prior Drug Treatment Eprosartan mesilate/hydrochlorothiazide | 2 participants |
| Prior Drug Treatment Erdosteine | 6 participants |
| Prior Drug Treatment Ergenyl chrono | 2 participants |
| Prior Drug Treatment Erlotinib hydrochloride | 1 participants |
| Prior Drug Treatment Erythromycin ethylsuccinate | 1 participants |
| Prior Drug Treatment Escitalopram | 3 participants |
| Prior Drug Treatment Esomeprazole | 3 participants |
| Prior Drug Treatment Esomeprazole magnesium | 3 participants |
| Prior Drug Treatment Etizolam | 1 participants |
| Prior Drug Treatment Etoposide | 1 participants |
| Prior Drug Treatment Etoricoxib | 1 participants |
| Prior Drug Treatment Ezetimibe | 1 participants |
| Prior Drug Treatment Ezetimibe/simvastatin | 4 participants |
| Prior Drug Treatment Famotidine | 2 participants |
| Prior Drug Treatment Felodipine | 7 participants |
| Prior Drug Treatment Fenofibrate | 10 participants |
| Prior Drug Treatment Ferric hydroxide polymaltose complex | 1 participants |
| Prior Drug Treatment Ferrous sulfate | 1 participants |
| Prior Drug Treatment Fexofenadine | 1 participants |
| Prior Drug Treatment Fish oil | 1 participants |
| Prior Drug Treatment Flumazenil | 1 participants |
| Prior Drug Treatment Flunarizine | 1 participants |
| Prior Drug Treatment Fluoxetine | 2 participants |
| Prior Drug Treatment Folic acid | 4 participants |
| Prior Drug Treatment Formoterol | 3 participants |
| Prior Drug Treatment Formoterol fumarate | 2 participants |
| Prior Drug Treatment Fosinopril | 3 participants |
| Prior Drug Treatment Fosinopril sodium | 2 participants |
| Prior Drug Treatment Furosemide | 2 participants |
| Prior Drug Treatment Gabapentin | 1 participants |
| Prior Drug Treatment Gefarnate | 1 participants |
| Prior Drug Treatment General nutrients/herbal NOS | 1 participants |
| Prior Drug Treatment Ginkgo biloba | 1 participants |
| Prior Drug Treatment Glibenclamide | 1 participants |
| Prior Drug Treatment Gliclazide | 10 participants |
| Prior Drug Treatment Glimepiride | 12 participants |
| Prior Drug Treatment Glimepiride/metformin hydrochloride | 1 participants |
| Prior Drug Treatment Glipizide | 3 participants |
| Prior Drug Treatment Gliquidone | 1 participants |
| Prior Drug Treatment Glucose | 2 participants |
| Prior Drug Treatment Glyceryl trinitrate | 4 participants |
| Prior Drug Treatment Guaifenesin | 1 participants |
| Prior Drug Treatment Hedera helix | 4 participants |
| Prior Drug Treatment Herbal preparation | 13 participants |
| Prior Drug Treatment Homeopatic preparation | 8 participants |
| Prior Drug Treatment Hyaluronate sodium | 1 participants |
| Prior Drug Treatment Hydrochlorothiazide | 7 participants |
| Prior Drug Treatment Hydrocortisone | 1 participants |
| Prior Drug Treatment Hydrotalcite | 1 participants |
| Prior Drug Treatment Hyzaar | 2 participants |
| Prior Drug Treatment Indapamide | 1 participants |
| Prior Drug Treatment Indometacin | 1 participants |
| Prior Drug Treatment Infliximab | 1 participants |
| Prior Drug Treatment Inosine | 1 participants |
| Prior Drug Treatment Insulin | 8 participants |
| Prior Drug Treatment Insulin aspart | 1 participants |
| Prior Drug Treatment Insulin glargine | 2 participants |
| Prior Drug Treatment Insulin glulisine | 1 participants |
| Prior Drug Treatment Insulin human | 3 participants |
| Prior Drug Treatment Insulin human injection, isophane | 2 participants |
| Prior Drug Treatment Ipratropium | 1 participants |
| Prior Drug Treatment Ipratropium bromide | 4 participants |
| Prior Drug Treatment Irbesartan | 13 participants |
| Prior Drug Treatment Isosorbide dinitrate | 2 participants |
| Prior Drug Treatment Isosorbide mononitrate | 11 participants |
| Prior Drug Treatment Isotretinoin | 1 participants |
| Prior Drug Treatment Itavastatin | 6 participants |
| Prior Drug Treatment Itopride | 1 participants |
| Prior Drug Treatment Itopride hydrochloride | 1 participants |
| Prior Drug Treatment Karvea hct | 3 participants |
| Prior Drug Treatment Kombipak II | 1 participants |
| Prior Drug Treatment Lacidipine | 1 participants |
| Prior Drug Treatment Lactitol | 1 participants |
| Prior Drug Treatment Lamivudine | 3 participants |
| Prior Drug Treatment Lansoprazole | 1 participants |
| Prior Drug Treatment Lekovit Ca | 2 participants |
| Prior Drug Treatment Lercanidipine | 1 participants |
| Prior Drug Treatment Lercanidipine hydrochloride | 1 participants |
| Prior Drug Treatment Levamlodipine besylate | 2 participants |
| Prior Drug Treatment Levocloperastine fendizoate | 3 participants |
| Prior Drug Treatment Levodropropizine | 4 participants |
| Prior Drug Treatment Levofloxacin | 8 participants |
| Prior Drug Treatment Levofloxacin hydrochloride | 5 participants |
| Prior Drug Treatment Levosalbutamol hydrochloride | 1 participants |
| Prior Drug Treatment Levosulpiride | 3 participants |
| Prior Drug Treatment Levothyroxine sodium | 3 participants |
| Prior Drug Treatment Liquorice | 1 participants |
| Prior Drug Treatment Lisinopril | 2 participants |
| Prior Drug Treatment Lithium carbonate | 1 participants |
| Prior Drug Treatment Loratadine | 1 participants |
| Prior Drug Treatment Lorazepam | 1 participants |
| Prior Drug Treatment Losartan | 7 participants |
| Prior Drug Treatment Losartan potassium | 8 participants |
| Prior Drug Treatment Magnesium hydroxide | 2 participants |
| Prior Drug Treatment Mecobalamin | 1 participants |
| Prior Drug Treatment Medilac-S | 1 participants |
| Prior Drug Treatment Mesalazine | 1 participants |
| Prior Drug Treatment Metformin | 29 participants |
| Prior Drug Treatment Metformin hydrochloride | 15 participants |
| Prior Drug Treatment Metformin hydrochloride/rosiglitazone | 1 participants |
| Prior Drug Treatment Metformin hydrochloride/sitagliptin | 1 participants |
| Prior Drug Treatment Methoxyphenamine | 1 participants |
| Prior Drug Treatment Methylprednisolone | 3 participants |
| Prior Drug Treatment Metoprolol | 11 participants |
| Prior Drug Treatment Metoprolol succinate | 3 participants |
| Prior Drug Treatment Metoprolol tartrate | 6 participants |
| Prior Drug Treatment Midazolam | 2 participants |
| Prior Drug Treatment Milnacipran hydrochloride | 1 participants |
| Prior Drug Treatment Mirtazapine | 1 participants |
| Prior Drug Treatment Molsidomine | 2 participants |
| Prior Drug Treatment Mometasone | 1 participants |
| Prior Drug Treatment Montelukast | 3 participants |
| Prior Drug Treatment Montelukast sodium | 4 participants |
| Prior Drug Treatment Mosapride | 1 participants |
| Prior Drug Treatment Mosapride citrate | 4 participants |
| Prior Drug Treatment Moxifloxacin hydrochloride | 2 participants |
| Prior Drug Treatment Multivitamins, plain | 2 participants |
| Prior Drug Treatment Myrtol | 3 participants |
| Prior Drug Treatment Naltrexone | 1 participants |
| Prior Drug Treatment Nateglinide | 4 participants |
| Prior Drug Treatment Nebivolol | 1 participants |
| Prior Drug Treatment Nicorandil | 5 participants |
| Prior Drug Treatment Nicotinic acid | 2 participants |
| Prior Drug Treatment Nifedipine | 16 participants |
| Prior Drug Treatment Nimodipine | 2 participants |
| Prior Drug Treatment Nisoldipine | 1 participants |
| Prior Drug Treatment Nitrendipine | 1 participants |
| Prior Drug Treatment Olanzapine | 2 participants |
| Prior Drug Treatment Olmesartan | 5 participants |
| Prior Drug Treatment Omega-3 marine triglycerides | 1 participants |
| Prior Drug Treatment Omega-3 triglycerides | 3 participants |
| Prior Drug Treatment Omeprazole | 3 participants |
| Prior Drug Treatment Orlistat | 2 participants |
| Prior Drug Treatment Oxazepam | 2 participants |
| Prior Drug Treatment Oxcarbazepine | 1 participants |
| Prior Drug Treatment Oxycodone hydrochloride | 1 participants |
| Prior Drug Treatment Pantoprazole | 1 participants |
| Prior Drug Treatment Pantoprazole sodium | 4 participants |
| Prior Drug Treatment Paracetamol | 5 participants |
| Prior Drug Treatment Paroxetine | 1 participants |
| Prior Drug Treatment Paroxetine hydrochloride | 1 participants |
| Prior Drug Treatment Penicillin NOS | 1 participants |
| Prior Drug Treatment Perindopril | 8 participants |
| Prior Drug Treatment Pethidine hydrochloride | 1 participants |
| Prior Drug Treatment Phenytoin sodium | 1 participants |
| Prior Drug Treatment Phosphatidyl choline | 1 participants |
| Prior Drug Treatment Pioglitazone | 3 participants |
| Prior Drug Treatment Pioglitazone hydrochloride | 3 participants |
| Prior Drug Treatment Pip/tazo | 1 participants |
| Prior Drug Treatment Platelets, human blood | 1 participants |
| Prior Drug Treatment Polycarbophil calcium | 1 participants |
| Prior Drug Treatment Pranlukast hydrate | 1 participants |
| Prior Drug Treatment Pravastatin | 7 participants |
| Prior Drug Treatment Pravastatin sodium | 4 participants |
| Prior Drug Treatment Prednisolone | 4 participants |
| Prior Drug Treatment Pregabalin | 2 participants |
| Prior Drug Treatment Procaterol | 2 participants |
| Prior Drug Treatment Propranolol | 1 participants |
| Prior Drug Treatment Propranolol hydrochloride | 1 participants |
| Prior Drug Treatment Pseudoephedrine hydrochloride | 1 participants |
| Prior Drug Treatment Pyridoxine hydrochloride | 1 participants |
| Prior Drug Treatment Quetiapine fumarate | 2 participants |
| Prior Drug Treatment Rabeprazole | 3 participants |
| Prior Drug Treatment Rabeprazole sodium | 2 participants |
| Prior Drug Treatment Ramipril | 4 participants |
| Prior Drug Treatment Ranitidine | 1 participants |
| Prior Drug Treatment Ranitidine hydrochloride | 3 participants |
| Prior Drug Treatment Rebamipide | 12 participants |
| Prior Drug Treatment Repaglinide | 3 participants |
| Prior Drug Treatment Risedronic acid | 1 participants |
| Prior Drug Treatment Risperidone | 2 participants |
| Prior Drug Treatment Rosiglitazone maleate | 1 participants |
| Prior Drug Treatment Rosuvastatin | 14 participants |
| Prior Drug Treatment Rosuvastatin calcium | 1 participants |
| Prior Drug Treatment Roxithromycin | 1 participants |
| Prior Drug Treatment Salbutamol | 7 participants |
| Prior Drug Treatment Salbutamol sulfate | 1 participants |
| Prior Drug Treatment Salmeterol | 1 participants |
| Prior Drug Treatment Salmeterol xinafoate | 3 participants |
| Prior Drug Treatment Salvia miltiorrhiza | 1 participants |
| Prior Drug Treatment Sarpogrelate hydrochloride | 2 participants |
| Prior Drug Treatment Selective beta-2-adrenoreceptor agonists | 1 participants |
| Prior Drug Treatment Selegiline hydrochloride | 1 participants |
| Prior Drug Treatment Seretide mite | 15 participants |
| Prior Drug Treatment Sertraline | 1 participants |
| Prior Drug Treatment Sibutramine | 1 participants |
| Prior Drug Treatment Sildenafil citrate | 2 participants |
| Prior Drug Treatment Silymarin | 1 participants |
| Prior Drug Treatment Simvastatin | 19 participants |
| Prior Drug Treatment Sinemet | 1 participants |
| Prior Drug Treatment Sinilgel | 1 participants |
| Prior Drug Treatment Sitagliptin | 6 participants |
| Prior Drug Treatment Sodium chloride | 1 participants |
| Prior Drug Treatment Sotalol hydrochloride | 1 participants |
| Prior Drug Treatment Spironolactone | 2 participants |
| Prior Drug Treatment Streptomycin | 1 participants |
| Prior Drug Treatment Sucralfate | 1 participants |
| Prior Drug Treatment Sulglicotide | 2 participants |
| Prior Drug Treatment Sulodexide | 1 participants |
| Prior Drug Treatment Symbicort turbuhaler draco | 6 participants |
| Prior Drug Treatment Tamsulosin | 5 participants |
| Prior Drug Treatment Tamsulosin hydrochloride | 3 participants |
| Prior Drug Treatment Tazobactam sodium | 2 participants |
| Prior Drug Treatment Telmisartan | 8 participants |
| Prior Drug Treatment Terazosin | 1 participants |
| Prior Drug Treatment Terazosin hydrochloride | 1 participants |
| Prior Drug Treatment Terbutaline sulfate | 1 participants |
| Prior Drug Treatment Theophylline | 7 participants |
| Prior Drug Treatment Thiamazole | 2 participants |
| Prior Drug Treatment Thioctic acid | 1 participants |
| Prior Drug Treatment Throat preparations | 1 participants |
| Prior Drug Treatment Tianeptine | 1 participants |
| Prior Drug Treatment Ticlopidine | 1 participants |
| Prior Drug Treatment Tiotropium | 10 participants |
| Prior Drug Treatment Tiotropium bromide | 2 participants |
| Prior Drug Treatment Tiotropium bromide/formoterol fumarate | 1 participants |
| Prior Drug Treatment Tiropramide hydrochloride | 2 participants |
| Prior Drug Treatment Tocopherol | 1 participants |
| Prior Drug Treatment Tramadol hydrochloride | 1 participants |
| Prior Drug Treatment Tranexamic acid | 3 participants |
| Prior Drug Treatment Travad phosphate enema | 1 participants |
| Prior Drug Treatment Trazodone | 1 participants |
| Prior Drug Treatment Triaprin | 1 participants |
| Prior Drug Treatment Triflusal | 1 participants |
| Prior Drug Treatment Trimetazidine | 2 participants |
| Prior Drug Treatment Trimetazidine hydrochloride | 2 participants |
| Prior Drug Treatment Udenafil | 1 participants |
| Prior Drug Treatment Ultracet | 3 participants |
| Prior Drug Treatment Ursodeoxycholic acid | 4 participants |
| Prior Drug Treatment Valproate semisodium | 1 participants |
| Prior Drug Treatment Valsartan | 9 participants |
| Prior Drug Treatment Verapamil | 1 participants |
| Prior Drug Treatment Vildagliptin | 1 participants |
| Prior Drug Treatment Vitamins | 1 participants |
| Prior Drug Treatment Vitamins with minerals | 1 participants |
| Prior Drug Treatment Voglibose | 3 participants |
| Prior Drug Treatment Warfarin | 6 participants |
| Prior Drug Treatment Yeast | 1 participants |
| Prior Drug Treatment Zevit | 1 participants |
| Prior Drug Treatment Zolpidem | 5 participants |
| Prior Drug Treatment Zolpidem tartrate | 3 participants |
| Quit History : Main reasons for relapses after previous attempts Exposure to smoke environment | 227 participants |
| Quit History : Main reasons for relapses after previous attempts Family / Friends | 164 participants |
| Quit History : Main reasons for relapses after previous attempts Smoking is a habitual response to stress/pressure | 381 participants |
| Quit History : Main reasons for relapses after previous attempts Urge to smoke is too strong | 449 participants |
| Quit History : Main reasons for relapses after previous attempts Weight gain | 20 participants |
| Quit History : Reasons motivated participant to quit smoking Body image / appearance | 78 participants |
| Quit History : Reasons motivated participant to quit smoking Family / Friends | 902 participants |
| Quit History : Reasons motivated participant to quit smoking Health reasons | 1218 participants |
| Quit History : Reasons motivated participant to quit smoking Money / cost | 72 participants |
| Quit History : Reasons motivated participant to quit smoking Smoking ban in public places | 37 participants |
| Sex/Gender, Customized Female | 88 Participants |
| Sex/Gender, Customized Male | 1279 Participants |
| Sex/Gender, Customized Unspecified | 6 Participants |
| Smoking history: Average number of cigarettes smoked per day in the last year | 20.00 cigarettes |
| Smoking history : Did participant have frequent contact with someone who smoked No | 199 participants |
| Smoking history : Did participant have frequent contact with someone who smoked Yes | 1071 participants |
| Smoking history : Did participant live with someone who smoked No | 1040 participants |
| Smoking history : Did participant live with someone who smoked Yes | 247 participants |
| Smoking history: Lifetime serious quit attempts None | 16 participants |
| Smoking history: Lifetime serious quit attempts One | 322 participants |
| Smoking history: Lifetime serious quit attempts Three or more | 194 participants |
| Smoking history: Lifetime serious quit attempts Two | 117 participants |
| Smoking history: Longest period of abstinence in the last year | 0.0 Days |
| Smoking history : Number of times the participant has attempted to quit in past year | 0.0 Quit attempts |
| Smoking history : Participant categorized based on number of attempt to quit in the past year None | 738 participants |
| Smoking history : Participant categorized based on number of attempt to quit in the past year One | 285 participants |
| Smoking history : Participant categorized based on number of attempt to quit in the past year Three or more | 127 participants |
| Smoking history : Participant categorized based on number of attempt to quit in the past year Two | 107 participants |
| Smoking history: Total number of years participant smoked | 20.0 Years |
| Smoking related concurrent diseases Atherosclerotic vascular disease (n=1181) | 138 participants |
| Smoking related concurrent diseases Occlusive disease of non-coronary arteries(n=1183) | 21 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 379 / 1,373 |
| serious Total, serious adverse events | 11 / 1,373 |
Outcome results
Primary
Percentage of Participants With Smoking Abstinence at Week 12
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.
Time frame: Week 12
Population: Full analysis set (FAS) included all participants who received at least 1 dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With Smoking Abstinence at Week 12 | 46.40 percentage of participants |
Secondary
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
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).
Time frame: 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).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Varenicline | Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit | 10.0 cigarettes | Full Range 9.57 |
Secondary
CO Level at Last Observed Study Visit
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | CO Level at Last Observed Study Visit | 4.1 ppm | Standard Deviation 4.81 |
Secondary
Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
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.
Time frame: Last observed study visit (Week 12 or early termination [ET])
Population: FAS included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit | 50.30 percentage of participants |
Secondary
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
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.
Time frame: Week 3 through Week 11
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 3 (n= 677) | 31.3 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 4 (n= 799) | 38.2 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 5 (n= 988) | 45.4 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 6 (n= 959) | 47.8 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 7 (n= 888) | 49.5 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 8 (n= 812) | 51.6 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 9 (n= 765) | 55.2 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 10 (n= 702) | 55.4 percentage of participants |
| Varenicline | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 11 (n= 605) | 59.2 percentage of participants |
Other Pre-specified
Average Daily Dose of Varenicline
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Average Daily Dose of Varenicline | Days 1-3 | 0.5 mg | Full Range 0.13 |
| Varenicline | Average Daily Dose of Varenicline | Days 4-7 (n=1347) | 1.0 mg | Full Range 0.21 |
| Varenicline | Average Daily Dose of Varenicline | Day 8 - Last observed study visit (n=1284) | 2.0 mg | Full Range 0.27 |
Other Pre-specified
Concomitant Drug Treatments
Time frame: Baseline through Last observed study visit (Week 12 or ET)
Population: FAS included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Concomitant Drug Treatments | Amlodipine besilate/valsartan | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine camsilate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine maleate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine orotate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine/valsartan | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Bepotastine besilate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Beraprost | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Beraprost sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Berberine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Beszyme | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Betahistine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Acamprosate | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Acarbose | 17 Participants |
| Varenicline | Concomitant Drug Treatments | Aceclofenac | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Acetylcarnitine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Acetylcysteine | 14 Participants |
| Varenicline | Concomitant Drug Treatments | Acetylsalicylic acid | 110 Participants |
| Varenicline | Concomitant Drug Treatments | Acetylsalicylic acid/atorvastatin/ramipril | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Acetylsalicylic acid/clopidogrel | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Adenine/biphenyldimethyldicarboxylate/vitamins | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Albumin human | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Alfuzosin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | All other therapeutic products | 11 Participants |
| Varenicline | Concomitant Drug Treatments | Allopurinol | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Almagate | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Almagel | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Alprazolam | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Aluminum hydroxide/magnesium carbonate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Amantadine hydrochloride / paracetamol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ambroxol | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Ambroxol acefyllinate | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Ambroxol hydrochloride | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Amikacin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Amino acids | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amino acids NOS/carbohydrates NOS/electrolytes NOS | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Aminophylline | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Amisulpride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amitriptyline hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine | 18 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine besilate | 21 Participants |
| Varenicline | Concomitant Drug Treatments | Amlodipine besilate/atorvastatin calcium | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Ammonium Cl/chlorpheniramine maleate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Amoxicillin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Amoxicillin sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Anisodamine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Antacids | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Antidiarrhoeal microorganisms | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Antisterone | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Aripiprazole | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Aronamin gold | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Arotinolol hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Artemisia asiatica | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Artemisia asiatica/ethanol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Asasantin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Asmeton | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Atenolol | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Atorvastatin | 54 Participants |
| Varenicline | Concomitant Drug Treatments | Atorvastatin calcium | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Atorvastatin/fenofibrate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Azathioprine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Azelastine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Azelastine hydrochloride | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Azithromycin | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Aztreonam | 1 Participants |
| Varenicline | Concomitant Drug Treatments | B-komplex leciva | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bambuterol hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Becosules syrup | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Becosym forte | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Becotal | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Benazepril | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Benazepril hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Benexate hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Benproperine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Benproperine phosphate | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Benzodiazepine derivatives | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bevantolol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Biselect | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bismuth subcitrate tripotassium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bismuth subcitrate tripotassium/ranitidine HCl | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Bisoprolol | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Bisoprolol fumarate | 13 Participants |
| Varenicline | Concomitant Drug Treatments | Borneol/notoginseng/salvia miltiorrhiza | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bromelains/dehydrocholic/pancreatin/simeticone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bromhexine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Broncho-vaxom | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Budesonide | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Bufferin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Bupropion | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Bupropion hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Buspiron | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Buspirone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Calcitriol / calcium citrate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Calcium citrate/colecalciferol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Calcium lactate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Candesartan | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Candesartan cilexetil | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Carbazochrome | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cardiovascular system drugs | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Carvedilol | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Cefaclor | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Cefalexin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cefcapene pivoxil hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Cefixime | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Cefoperazone sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cefpodoxime | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Cefpodoxime proxetil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cefradine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ceftriaxone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ceftriaxone sodium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Cefuroxime | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cefuroxime axetil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cefuroxime sodium | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Celecoxib | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cephalosporins and related substances | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Cetirizine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Chlordiazepoxide/clidinium bromide/dicycloverine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Chlormadinone acetate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Chlorphenamine maleate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Chlorphenesin carbamate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Choline alfoscerate | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Chondroitin/glucosamine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cilazapril | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Cilnidipine | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Cilostazol | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Cimetidine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Cimetropium bromide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cinnarizine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ciprofloxacin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ciprofloxacin hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Citalopram | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Citicoline | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Clarithromycin | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Clavulin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Clobazam | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Clonazepam | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Furosemide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Clopidogrel | 21 Participants |
| Varenicline | Concomitant Drug Treatments | Clopidogrel sulfate | 16 Participants |
| Varenicline | Concomitant Drug Treatments | Co-diovan | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Colchicine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Cordalin/old form/ | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cotylenol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cough syrup | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Cyproterone acetate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Desmopressin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Desonide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Dexamethasone | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Dexamethasone/neomycin sulfate/polymyxin B sulfate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Diazepam | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Diclofenac | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Digoxin | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Dihydrocodeine bitartrate | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Diloxanide furoate/metronidazole | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Diltiazem | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Diltiazem hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Dimenhydrinate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Disulfiram | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Docetaxel | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Domperidone | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Domperidone maleate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Domperidone/pantoprazole | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Domperidone/rabeprazole | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Domperidone/rabeprazole sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Donepezil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Doxazosin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Doxazosin mesilate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Doxofylline | 21 Participants |
| Varenicline | Concomitant Drug Treatments | Drotaverine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Drug, unspecified | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Duloxetine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Duloxetine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ebastine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ecabet monosodium | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Efavirenz/emtricitabine/tenofovir | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Efonidipine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Enalapril | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Enalapril maleate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Epoprostenol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Eprosartan | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Eprosartan mesilate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Eprosartan mesilate/hydrochlorothiazide | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Erdosteine | 14 Participants |
| Varenicline | Concomitant Drug Treatments | Ergenyl chrono | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Erlotinib hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Erythromycin ethylsuccinate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Escitalopram | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Esomeprazole | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Esomeprazole magnesium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Estazolam | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Etizolam | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Etoposide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Etoricoxib | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ezetimibe | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ezetimibe/simvastatin | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Famotidine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Felodipine | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Fenofibrate | 11 Participants |
| Varenicline | Concomitant Drug Treatments | Ferric hydroxide polymaltose complex | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ferrous sulfate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fexofenadine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Fexofenadine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fish oil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Flunarizine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fluoxetine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Fluoxetine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fluticasone propionate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fluvastatin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Folic acid | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Folic acid/mecobalamin/pyridoxine hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Foraseq | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Formoterol | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Formoterol fumarate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Fosinopril | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Fosinopril sodium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Gabapentin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Galenic /fluticasone/salmeterol | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Galenic /salbutamol/guaifenesin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | General nutrients/minerals/vitamins | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ginkgo biloba | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ginkgo biloba extract | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Glibenclamide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Gliclazide | 12 Participants |
| Varenicline | Concomitant Drug Treatments | Glimepiride | 13 Participants |
| Varenicline | Concomitant Drug Treatments | Glimepiride/metformin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Glimepiride/metformin hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Glipizide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Gliquidone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Glucose | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Glyceryl trinitrate | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Guaifenesin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Hedera helix | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Heparin-fraction | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Hepatitis B vaccine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Herbal preparation | 13 Participants |
| Varenicline | Concomitant Drug Treatments | Homeopatic preparation | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Hyaluronate sodium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Hydrochlorothiazide | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Hydrotalcite | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Hydroxychloroquine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Hydroxyzine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Hydroxyzine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Hyoscine butylbromide | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Hyzaar | 2 Participants |
| Varenicline | Concomitant Drug Treatments | I.v. solutions | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ibuprofen | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Indapamide | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Indometacin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Infliximab | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Inosine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin aspart | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin glargine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin glulisine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin human | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Insulin human injection, isophane | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ipratropium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ipratropium bromide | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Irbesartan | 14 Participants |
| Varenicline | Concomitant Drug Treatments | Isoconazole nitrate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Isosorbide dinitrate | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Isosorbide mononitrate | 11 Participants |
| Varenicline | Concomitant Drug Treatments | Isotretinoin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ispaghula | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ispaghula husk | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Itavastatin | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Itopride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Itopride hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Itraconazole | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Karvea hct | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Kombipak II | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lacidipine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lactitol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lactulose | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Lamivudine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Lansoprazole | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Lekovit Ca | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Lenograstim | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lercanidipine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lercanidipine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Levamlodipine besylate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Levocarnitine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Levocetirizine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Levocetirizine dihydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Levocetirizine dihydrochloride/montelukast sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Naltrexone | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Levocloperastine fendizoate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Levodropropizine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Levofloxacin | 14 Participants |
| Varenicline | Concomitant Drug Treatments | Levofloxacin hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Levosalbutamol hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Levosulpiride | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Levothyroxine sodium | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Lipase | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Lisinopril | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Lithium carbonate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Loperamide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Loratadine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Lorazepam | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Losartan | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Losartan potassium | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Magnesium hydroxide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Magnesium oxide | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Mecobalamin | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Medilac-S | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Mefloquine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Megestrol acetate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Meprobamate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Meropenem | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Mesalazine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Metformin | 32 Participants |
| Varenicline | Concomitant Drug Treatments | Metformin hydrochloride | 16 Participants |
| Varenicline | Concomitant Drug Treatments | Metformin hydrochloride/rosiglitazone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Metformin hydrochloride/sitagliptin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Methoxyphenamine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Methylprednisolone | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Metoclopramide | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Metoclopramide hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Metoprolol | 13 Participants |
| Varenicline | Concomitant Drug Treatments | Metoprolol succinate | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Metoprolol tartrate | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Metronidazole | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Milnacipran | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Milnacipran hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Mirtazapine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Mobizox | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Molsidomine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Mometasone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Mometasone furoate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Montelukast | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Montelukast sodium | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Mosapride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Mosapride citrate | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Moxifloxacin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Moxifloxacin hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Mucaine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Multivitamins with minerals | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Multivitamins, plain | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Myprodol rio ethicals | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Myrin plus | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Myrtol | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Naproxen | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Nateglinide | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Nebivolol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Nicorandil | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Nicotine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Nicotinic acid | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Nifedipine | 16 Participants |
| Varenicline | Concomitant Drug Treatments | Nimesulide/paracetamol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Nimodipine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Nisoldipine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Nitrendipine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Nizatidine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ofloxacin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Olanzapine | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Olmesartan | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Olmesartan medoxomil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Omega-3 marine triglycerides | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Omega-3 triglycerides | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Omeprazole | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Ondansetron | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ondansetron hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Orlistat | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Oxazepam | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Oxcarbazepine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Oxycodone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Oxycodone hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Palonosetron hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Phenylephrine/triprolidine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pantoprazole | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Pantoprazole sodium | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Paracetamol | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Paroxetine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Paroxetine hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Pentamycin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Perindopril | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Phenytoin sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Phosphatidyl choline | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Phytomenadione | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pinaverium bromide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pioglitazone | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Pioglitazone hydrochloride | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Platelets, human blood | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pneumococcal vaccine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Polycarbophil calcium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Pramipexole | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Pranlukast hydrate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pravastatin | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Pravastatin sodium | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Prednicarbate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Prednisolone | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Pregabalin | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Procaterol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Promethazine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pronase | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Propranolol | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Propranolol hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Propylthiouracil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pseudoephedrine hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Pyridostigmine bromide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Pyridoxine hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Quetiapine fumarate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Rabeprazole | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Rabeprazole sodium | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Raloxifene | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Ramipril | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Ranitidine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Ranitidine hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Rebamipide | 12 Participants |
| Varenicline | Concomitant Drug Treatments | Repaglinide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Rino ebastel | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Riopan plus | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Risedronic acid | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Risperidone | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Rosiglitazone maleate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Sulglicotide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Rosuvastatin | 24 Participants |
| Varenicline | Concomitant Drug Treatments | Rosuvastatin calcium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Roxithromycin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Salbutamol | 9 Participants |
| Varenicline | Concomitant Drug Treatments | Salbutamol sulfate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Salmeterol | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Salmeterol xinafoate | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Salvia miltiorrhiza | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sarpogrelate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sarpogrelate hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Selective beta-2-adrenoreceptor agonists | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Selegiline hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Seretide allen & hanburys ltd | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Seretide mite | 17 Participants |
| Varenicline | Concomitant Drug Treatments | Sertraline | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Sibutramine | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Sibutramine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sildenafil citrate | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Silymarin | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Simeco | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Simvastatin | 21 Participants |
| Varenicline | Concomitant Drug Treatments | Sinemet | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sirolin retard | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Sitagliptin | 6 Participants |
| Varenicline | Concomitant Drug Treatments | Sodium chloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sotalol hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Spedifen | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Spirapril hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Spironolactone | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Spironolactone / torasemide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Streptomycin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sucralfate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Sulodexide | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Symbicort turbuhaler draco | 11 Participants |
| Varenicline | Concomitant Drug Treatments | Tadalafil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tamsulosin | 5 Participants |
| Varenicline | Concomitant Drug Treatments | Tamsulosin hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Tazobactam sodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Telmisartan | 17 Participants |
| Varenicline | Concomitant Drug Treatments | Terazosin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Terazosin hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Terbinafine hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Terbutaline | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Terbutaline sulfate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Testosterone undecanoate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Theophylline | 18 Participants |
| Varenicline | Concomitant Drug Treatments | Thiamazole | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Thioctic acid | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Throat preparations | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tianeptine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Ticlopidine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tiotropium | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Tiotropium bromide | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Tiotropium bromide/formoterol fumarate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tiropramide hydrochloride | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Tocopherol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tolterodine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tramadol | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tramadol hydrochloride | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Tranexamic acid | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Trazodone | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Triaprin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Triazolam | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Triflusal | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Trihexyphenidyl | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Trimebutine | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Trimebutine maleate | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Trimetazidine | 4 Participants |
| Varenicline | Concomitant Drug Treatments | Trimetazidine hydrochloride | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Tromcardin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Udenafil | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Ultracet | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Ursodeoxycholic acid | 8 Participants |
| Varenicline | Concomitant Drug Treatments | Valproate semisodium | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Valsartan | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Varidase | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Verapamil | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Vildagliptin | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Vitamin B | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Vitamins | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Vitamins with minerals | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Vitamins, other combinations | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Voglibose | 3 Participants |
| Varenicline | Concomitant Drug Treatments | Warfarin | 7 Participants |
| Varenicline | Concomitant Drug Treatments | Yeast | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Zevit | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Zinc | 1 Participants |
| Varenicline | Concomitant Drug Treatments | Zoledronic acid | 2 Participants |
| Varenicline | Concomitant Drug Treatments | Zolpidem | 10 Participants |
| Varenicline | Concomitant Drug Treatments | Zolpidem tartrate | 6 Participants |
Other Pre-specified
Median Duration of Treatment of Varenicline
The duration was defined as the total number of dosing days from first to last day of each study treatment.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Varenicline | Median Duration of Treatment of Varenicline | 43.0 Days |
Other Pre-specified
Varenicline Prescription Status
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'.
Time frame: After last observed study visit (Week 12 or ET)
Population: FAS population included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Varenicline Prescription Status | Prescription status = No | 962 participants |
| Varenicline | Varenicline Prescription Status | Prescription status = Unknown | 266 participants |
| Varenicline | Varenicline Prescription Status | Prescription status = Yes | 145 participants |