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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
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STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to help people stop smoking by using very low nicotine content (VLNC) cigarettes. This developmental pilot study (n=20) will determine the feasibility of the treatment approach and methodology using a targeted intervention, and lead to refinements for a subsequent randomized controlled trial (RCT).
STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if a targeted intervention will help people to stop or reduce smoking better than a standard intervention using very low nicotine content (VLNC) cigarettes, and to determine the optimal nicotine tapering schedule (gradual vs. immediate) during a 5-week pre-quit period. About 208 participants will take part in this phase of the study at Moffitt Cancer Center.
The current project will (1) develop a theory-based, user-friendly, and efficient set of targeted cessation materials to facilitate extinction during pre-quit VLNC smoking, (2) establish the feasibility of recruitment and measurement strategies to be used in the RCT, (3) determine whether immediate vs. gradual pre-quit nicotine tapering in combination with the targeted behavioral intervention has beneficial effects (on cessation-related and intermediate outcomes) for eventual comparison with validated cessation methods (e.g., NRT), and (4) examine several potential moderators and mediators of treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1: Immediate Reduction | Experimental | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
|
| Study 1: Gradual Reduction | Experimental | Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
|
| Study 2: Targeted/Immediate Reduction | Experimental | Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
|
| Study 2: Targeted/Gradual Reduction | Experimental | Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Nicotine Content (VLNC) Cigarettes | Drug | Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Study 1 - Rate of Participant Completion of Pilot | Pilot: Complete formative research based on 15 participants to prepare for Study 2. | Up to 2 Weeks |
| Study 2 - Participant Abstinence Success at 2 Months | Participants reporting 7-day point prevalence abstinence at 2 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment. | At 2 Months |
| Study 2 - Participant Abstinence Success at 6 Months | Participants reporting 7-day point prevalence abstinence at 6 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment. | At 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vani Simmons, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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1 participant did not meet inclusion criteria in study 1 before being assigned to an arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study 1: Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
| FG001 | Study 1: Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
| FG002 | Study 2: Targeted/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling. |
| FG003 | Study 2: Targeted/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling. |
| FG004 | Study 2: Generic/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. |
| FG005 | Study 2: Generic/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study 1: Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Study 1 - Rate of Participant Completion of Pilot | Pilot: Complete formative research based on 15 participants to prepare for Study 2. | Posted | Count of Participants | Participants | Up to 2 Weeks |
|
Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
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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 | Study 1: Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vani Simmons | Moffitt Cancer Center | 813-745-4816 | Vani.Simmons@moffitt.org |
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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 | Jun 30, 2021 | Sep 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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|
| Study 2: Generic/Immediate Reduction | Experimental | Participants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. |
|
| Study 2: Generic/Gradual Reduction | Experimental | Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. |
|
|
|
| One on One Counseling | Behavioral | All participants will receive One on One Counseling. |
|
| COVID |
|
| Participant did not like study cigarettes |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Protocol Violation |
|
| Study 1: Gradual Reduction |
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. |
| BG002 | Study 2: Targeted/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling. |
| BG003 | Study 2: Targeted/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling. |
| BG004 | Study 2: Generic/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. |
| BG005 | Study 2: Generic/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Study 1: Gradual Reduction | This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction). Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling. Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. One on One Counseling: All participants will receive One on One Counseling. |
|
|
| Primary | Study 2 - Participant Abstinence Success at 2 Months | Participants reporting 7-day point prevalence abstinence at 2 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment. | Posted | Number | participants | At 2 Months |
|
|
|
| Primary | Study 2 - Participant Abstinence Success at 6 Months | Participants reporting 7-day point prevalence abstinence at 6 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment. | Posted | Number | participants | At 6 Months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 5 |
| 7 |
| EG001 | Study 1: Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | Study 2: Targeted/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling. | 0 | 41 | 0 | 41 | 25 | 41 |
| EG003 | Study 2: Targeted/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling. | 0 | 32 | 3 | 32 | 20 | 32 |
| EG004 | Study 2: Generic/Immediate Reduction | Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. | 0 | 34 | 1 | 34 | 24 | 34 |
| EG005 | Study 2: Generic/Gradual Reduction | Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling | 0 | 40 | 2 | 40 | 27 | 40 |
| Chest Pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergic Reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tooth discoloration | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Irritability | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Carbon monoxide diffusing capacity decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Concentration impairment | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Trigeminal nerve disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Suicidal ideation | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urticaria | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Squamous cell spot | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cramping | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided