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This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Smoking Cessation Treatment Coverage (100%) | Other | A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization. |
|
| No Smoking Cessation Treatment Coverage (0%) | Other | Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Smoking Cessation Treatment Coverage (100%) | Other | This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?" | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?" confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Burnaby | British Columbia | V5G 1T4 | Canada | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24885542 | Derived | Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reimbursement for Smoking Cessation Therapy (SCT) | Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| No Smoking Cessation Treatment Coverage (0%) | Other | None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation. |
|
| Week 26 |
| Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions "Have you smoked any cigarettes (even a puff) since the last contact/visit?" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?" and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing. | Week 26, Week 39, and Week 52 |
| Percentage of Participants With 7-Day PP of Abstinence at Week 13 | PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" | Week 13 |
| Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52 | Week 26 to Week 52 |
| Chilliwack |
| British Columbia |
| V2P 4M9 |
| Canada |
| Pfizer Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Pfizer Investigational Site | Kamloops | British Columbia | V2C 1K7 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Pfizer Investigational Site | Langley | British Columbia | V3A 4H9 | Canada |
| Pfizer Investigational Site | North Vancouver | British Columbia | V7N 4M2 | Canada |
| Pfizer Investigational Site | Penticton | British Columbia | V2A 5C8 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V5K 1K3 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Pfizer Investigational Site | Victoria | British Columbia | V8R 1J8 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2M 3T2 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2V 4W3 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Pfizer Investigational Site | Bay Roberts | Newfoundland and Labrador | A0A 1G0 | Canada |
| Pfizer Investigational Site | Paradise | Newfoundland and Labrador | A1L 1C6 | Canada |
| Pfizer Investigational Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Pfizer Investigational Site | St. John's | Newfoundland and Labrador | A1E 2E2 | Canada |
| Pfizer Investigational Site | Sydney | Nova Scotia | B1P 1C6 | Canada |
| Pfizer Investigational Site | Windsor | Nova Scotia | B0N 2T0 | Canada |
| Pfizer Investigational Site | Aylmer | Ontario | N5H 1K9 | Canada |
| Pfizer Investigational Site | Bolton | Ontario | L7E 1E8 | Canada |
| Pfizer Investigational Site | Collingwood | Ontario | L9Y 1W3 | Canada |
| Pfizer Investigational Site | Corunna | Ontario | N0N 1G0 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8M 1K7 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 4A6 | Canada |
| Pfizer Investigational Site | London | Ontario | N5W 3C6 | Canada |
| Pfizer Investigational Site | London | Ontario | N5W 6A2 | Canada |
| Pfizer Investigational Site | London | Ontario | N5Y 5K7 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 5G6 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 5W9 | Canada |
| Pfizer Investigational Site | London | Ontario | N6C 4Y7 | Canada |
| Pfizer Investigational Site | London | Ontario | N6H 4P2 | Canada |
| Pfizer Investigational Site | London | Ontario | N6P 1A9 | Canada |
| Pfizer Investigational Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K2C 3R2 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Pfizer Investigational Site | Stayner | Ontario | L0M 1S0 | Canada |
| Pfizer Investigational Site | Strathroy | Ontario | N7G 1Y7 | Canada |
| Pfizer Investigational Site | Thornhill | Ontario | L4J 6W6 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 1N8 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6L 3C9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M8V 3X8 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Pfizer Investigational Site | Woodstock | Ontario | N4S 5P5 | Canada |
| Pfizer Investigational Site | Charlottetown | Prince Edward Island | C1A 1L2 | Canada |
| Pfizer Investigational Site | Charlottetown | Prince Edward Island | C1A 5Y9 | Canada |
| Pfizer Investigational Site | Montague | Prince Edward Island | C0A 1R0 | Canada |
| Pfizer Investigational Site | Regina | Saskatchewan | S4P 3X1 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 6Y6 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 7H9 | Canada |
| No Reimbursement for SCT |
Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reimbursement for Smoking Cessation Therapy (SCT) | Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization. |
| BG001 | No Reimbursement for SCT | Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?" | Intent to Treat (ITT) Population: all randomized participants | Posted | Number | Percentage of Participants | Week 26 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?" confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL]). | ITT | Posted | Number | Percentage of Participants | Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions "Have you smoked any cigarettes (even a puff) since the last contact/visit?" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?" and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing. | ITT | Posted | Number | Percentage of Participants | Week 26, Week 39, and Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 7-Day PP of Abstinence at Week 13 | PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" | ITT | Posted | Number | Percentage of Participants | Week 13 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52 | ITT | Posted | Number | Percentage of Participants | Week 26 to Week 52 |
|
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The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reimbursement for Smoking Cessation Therapy (SCT) | Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization. | 35 | 696 | 335 | 696 | ||
| EG001 | No Reimbursement for SCT | Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket. | 25 | 684 | 246 | 684 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder postoperative | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dissociative identity disorder | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Violence-related symptom | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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