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This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.
The objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. The guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. Participants will provide smoking self-report (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. After the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (Week 13, Week 18, and Week 26).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. |
|
| placebo | Placebo Comparator | Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment | Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit | 7 days at end of treatment |
| Number of Participants Experiencing Treatment-emergent Adverse Events | Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment. | 26 weeks (12 weeks of treatment plus full post-treatment follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Visits With Abstinence During Treatment | Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence. | 12 weeks (all of active treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Gray, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611902 | Derived | Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. | |
| 31609433 | Derived | Gray KM, Baker NL, McClure EA, Tomko RL, Squeglia LM, Saladin ME, Carpenter MJ. Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial. JAMA Pediatr. 2019 Dec 1;173(12):1146-1153. doi: 10.1001/jamapediatrics.2019.3553. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
| FG001 | Placebo | Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment | Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit | Intent-to-treat population | Posted | Count of Participants | Participants | 7 days at end of treatment |
|
6 months (randomization to last post-treatment follow-up visit)
Assessed and coded in MedDRA terminology by the medical clinician at each visit.
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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 | Varenicline | Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ear congestion | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin M. Gray, M.D. | Medical University of South Carolina | 843-792-6330 | graykm@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2016 | Mar 5, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2016 | Mar 5, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| placebo | Drug | participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
|
| Percentage of Post-treatment Visits With Abstinence |
Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence. |
| One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits |
| Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment | Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment | 12 weeks of active treatment |
| Physician Decision |
|
| BG001 | Placebo | Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. |
|
|
| Primary | Number of Participants Experiencing Treatment-emergent Adverse Events | Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment. | Posted | Count of Participants | Participants | 26 weeks (12 weeks of treatment plus full post-treatment follow-up) |
|
|
|
| Secondary | Percentage of Visits With Abstinence During Treatment | Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence. | Posted | Number | 95% Confidence Interval | percentage of visits with abstinence | 12 weeks (all of active treatment) |
|
|
|
| Secondary | Percentage of Post-treatment Visits With Abstinence | Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence. | Posted | Number | 95% Confidence Interval | percentage of visits with abstinence | One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits |
|
|
|
| Secondary | Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment | Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment | Posted | Count of Participants | Participants | 12 weeks of active treatment |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 55 |
| 77 |
| EG001 | Placebo | Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter. | 0 | 80 | 0 | 80 | 60 | 80 |
| blurred vision | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| conjunctivitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dyspepsia (worsening) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| salivary hypersecretion | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| stomachache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| boil | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| folliculitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| influenza like illness | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| laryngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| lung infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| oral herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| otitis media | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| vaginal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| viral upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| corneal abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| fractured coccyx | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| limb injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| pain in extremity | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| post operative pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| post procedural complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| skin abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| sprained ankle | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| sunburn | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| increased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| back muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| foot pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| lightheadedness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| memory impairment | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| migraine | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| migraine (worsening) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| poor quality sleep | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| agitation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| anxiety (worsening) | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| attention-deficit/hyperactivity disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| depressed mood | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| hostility | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypervigilance | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| inappropriate affect | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| irritability | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| mood swings | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| panic attack (worsening) | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| passive suicidal ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| tobacco withdrawal symptoms | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| vivid dreams | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| oliguria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| menorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| vaginal discharge | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| chest congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| lung infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| rhinitis seasonal (worsening) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| night sweats | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| rash generalized | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
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| D011810 | Quinoxalines |