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The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.
Same as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adapalene | Active Comparator | adapalene |
|
| tretinoin | Active Comparator | Tretinoin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalene gel, 0.3% | Drug | applied topically once daily in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 | Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst. | baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24 | Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Department of Dermatology | Ann Arbor | Michigan | 48109 | United States |
Wash-out period at baseline: 2 wks topical alpha-hydroxy, glycolic, salicylic, lactic, & beta-hydroxy acids, topical vitamin A, ascorbic acid, vitamin E, corticosteroids on face; 4 wks systemic corticosteroids; 3 mos topical retinoids, superficial chemical peels/exfoliation/microdermabrasion; 6 mos botulinum toxin on the face; 1 yr oral retinoids.
Dates of recruitment period: First subject was enrolled on June 17, 2008 and the last subject was enrolled on July 24, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Differin® Gel, 0.3% | adapalene gel 0.3% - apply once daily in the evening for 24 weeks |
| FG001 | Tretinoin Emollient Cream | Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Differin® Gel, 0.3% | adapalene gel 0.3% - apply once daily in the evening for 24 weeks |
| BG001 | Tretinoin Emollient Cream | Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks |
| 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 | Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 | Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst. | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | baseline to week 24 |
|
24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
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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 | Differin® Gel, 0.3% | adapalene gel 0.3% - apply once daily in the evening for 24 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site bleeding | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D005782 | Gels |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| tretinoin 0.05% emollient cream | Drug | applied topically once daily in the evening |
|
|
| baseline, week 12 and week 24 |
| Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12. | Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst. | baseline to week 12 |
| Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24 | Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst. | week 12 and week 24 |
| Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24 | Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst. | week 12 and week 24 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Surgery for pre-existing neck pain |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|
| Secondary | Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24 | Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst. | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | baseline, week 12 and week 24 |
|
|
|
| Secondary | Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12. | Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst. | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | baseline to week 12 |
|
|
|
| Secondary | Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24 | Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst. | ITT (Intent to Treat; LOCF (Last Observation Carried Forward) | Posted | Number | participants | week 12 and week 24 |
|
|
|
| Secondary | Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24 | Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst. | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | week 12 and week 24 |
|
|
|
| 0 |
| 15 |
| 7 |
| 15 |
| EG001 | Tretinoin Emollient Cream | Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks | 0 | 15 | 14 | 15 |
| Application site burn | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gonorrhea | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Streptococcal postoperative wound infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Terminal dribbling | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| Fine wrinkling baseline Mild (2) |
|
| Fine wrinkling baseline Moderate (3) |
|
| Fine wrinkling baseline Severe (4) |
|
| Fine wrinkling week 12 None (0) |
|
| Fine wrinkling week 12 Minimal (1) |
|
| Fine wrinkling week 12 Mild (2) |
|
| Fine wrinkling week 12 Moderate (3) |
|
| Fine wrinkling week 12 Severe (4) |
|
| Fine wrinkling week 24 None (0) |
|
| Fine wrinkling week 24 Minimal (1) |
|
| Fine wrinkling week 24 Mild (2) |
|
| Fine wrinkling week 24 Moderate (3) |
|
| Fine wrinkling week 24 Severe (4) |
|
| Mottled pigmentation baseline None (0) |
|
| Mottled pigmentation baseline Minimal (1) |
|
| Mottled pigmentation baseline Mild (2) |
|
| Mottled pigmentation baseline Moderate (3) |
|
| Mottled pigmentation baseline Severe (4) |
|
| Mottled pigmentation week 12 None (0) |
|
| Mottled pigmentation week 12 Minimal (1) |
|
| Mottled pigmentation week 12 Mild (2) |
|
| Mottled pigmentation week 12 Moderate (3) |
|
| Mottled pigmentation week 12 Severe (4) |
|
| Mottled pigmentation week 24 None (0) |
|
| Mottled pigmentation week 24 Minimal (1) |
|
| Mottled pigmentation week 24 Mild (2) |
|
| Mottled pigmentation week 24 Moderate (3) |
|
| Mottled pigmentation week 24 Severe (4) |
|
| Irregular depigmentation baseline None (0) |
|
| Irregular depigmentation baseline Minimal (1) |
|
| Irregular depigmentation baseline Mild (2) |
|
| Irregular depigmentation baseline Moderate (3) |
|
| Irregular depigmentation baseline Severe (4) |
|
| Irregular depigmentation week 12 None (0) |
|
| Irregular depigmentation week 12 Minimal (1) |
|
| Irregular depigmentation week 12 Mild (2) |
|
| Irregular depigmentation week 12 Moderate (3) |
|
| Irregular depigmentation week 12 Severe (4) |
|
| Irregular depigmentation week 24 None (0) |
|
| Irregular depigmentation week 24 Minimal (1) |
|
| Irregular depigmentation week 24 Mild (2) |
|
| Irregular depigmentation week 24 Moderate (3) |
|
| Irregular depigmentation week 24 Severe (4) |
|
| Lentigines baseline None (0) |
|
| Lentigines baseline Minimal (1) |
|
| Lentigines baseline Mild (2) |
|
| Lentigines baseline Moderate (3) |
|
| Lentigines baseline Severe (4) |
|
| Lentigines week 12 None (0) |
|
| Lentigines week 12 Minimal (1) |
|
| Lentigines week 12 Mild (2) |
|
| Lentigines week 12 Moderate (3) |
|
| Lentigines week 12 Severe (4) |
|
| Lentigines week 24 None (0) |
|
| Lentigines week 24 Minimal (1) |
|
| Lentigines week 24 Mild (2) |
|
| Lentigines week 24 Moderate (3) |
|
| Lentigines week 24 Severe (4) |
|
| Coarse wrinkling baseline None (0) |
|
| Coarse wrinkling baseline Minimal (1) |
|
| Coarse wrinkling baseline Mild (2) |
|
| Coarse wrinkling baseline Moderate (3) |
|
| Coarse wrinkling baseline Severe (4) |
|
| Coarse wrinkling week 12 None (0) |
|
| Coarse wrinkling week 12 Minimal (1) |
|
| Coarse wrinkling week 12 Mild (2) |
|
| Coarse wrinkling week 12 Moderate (3) |
|
| Coarse wrinkling week 12 Severe (4) |
|
| Coarse wrinkling week 24 None (0) |
|
| Coarse wrinkling week 24 Minimal (1) |
|
| Coarse wrinkling week 24 Mild (2) |
|
| Coarse wrinkling week 24 Moderate (3) |
|
| Coarse wrinkling week 24 Severe (4) |
|
| Elastosis baseline None (0) |
|
| Elastosis baseline Minimal (1) |
|
| Elastosis baseline Mild (2) |
|
| Elastosis baseline Moderate (3) |
|
| Elastosis baseline Severe (4) |
|
| Elastosis week 12 None (0) |
|
| Elastosis week 12 Minimal (1) |
|
| Elastosis week 12 Mild (2) |
|
| Elastosis week 12 Moderate (3) |
|
| Elastosis week 12 Severe (4) |
|
| Elastosis week 24 None (0) |
|
| Elastosis week 24 Minimal (1) |
|
| Elastosis week 24 Mild (2) |
|
| Elastosis week 24 Moderate (3) |
|
| Elastosis week 24 Severe (4) |
|
| Tactile Roughness baseline None (0) |
|
| Tactile Roughness baseline Minimal (1) |
|
| Tactile Roughness baseline Mild (2) |
|
| Tactile Roughness baseline Moderate (3) |
|
| Tactile Roughness baseline Severe (4) |
|
| Tactile Roughness week 12 None (0) |
|
| Tactile Roughness week 12 Minimal (1) |
|
| Tactile Roughness week 12 Mild (2) |
|
| Tactile Roughness week 12 Moderate (3) |
|
| Tactile Roughness week 12 Severe (4) |
|
| Tactile Roughness week 24 None (0) |
|
| Tactile Roughness week 24 Minimal (1) |
|
| Tactile Roughness week 24 Mild (2) |
|
| Tactile Roughness week 24 Moderate (3) |
|
| Tactile Roughness week 24 Severe (4) |
|
| Telangiectasia baseline None (0) |
|
| Telangiectasia baseline Minimal (1) |
|
| Telangiectasia baseline Mild (2) |
|
| Telangiectasia baseline Moderate (3) |
|
| Telangiectasia baseline Severe (4) |
|
| Telangiectasia week 12 None (0) |
|
| Telangiectasia week 12 Minimal (1) |
|
| Telangiectasia week 12 Mild (2) |
|
| Telangiectasia week 12 Moderate (3) |
|
| Telangiectasia week 12 Severe (4) |
|
| Telangiectasia week 24 None (0) |
|
| Telangiectasia week 24 Minimal (1) |
|
| Telangiectasia week 24 Mild (2) |
|
| Telangiectasia week 24 Moderate (3) |
|
| Telangiectasia week 24 Severe (4) |
|
| Actinic keratosis baseline None (0) |
|
| Actinic keratosis baseline Minimal (1) |
|
| Actinic keratosis baseline Mild (2) |
|
| Actinic keratosis baseline Moderate (3) |
|
| Actinic keratosis baseline Severe (4) |
|
| Actinic keratosis week 12 None (0) |
|
| Actinic keratosis week 12 Minimal (1) |
|
| Actinic keratosis week 12 Mild (2) |
|
| Actinic keratosis week 12 Moderate (3) |
|
| Actinic keratosis week 12 Severe (4) |
|
| Actinic keratosis week 24 None (0) |
|
| Actinic keratosis week 24 Minimal (1) |
|
| Actinic keratosis week 24 Mild (2) |
|
| Actinic keratosis week 24 Moderate (3) |
|
| Actinic keratosis week 24 Severe (4) |
|
| week 12 Marked Improvement |
|
| week 12 Moderate Improvement |
|
| week 12 Slight Improvement |
|
| week 12 No Change |
|
| week 12 Worse |
|
| week 12 Missing |
|
| week 24 Complete Improvement |
|
| week 24 Almost Complete Improvement |
|
| week 24 Marked Improvement |
|
| week 24 Moderate Improvement |
|
| week 24 Slight Improvement |
|
| week 24 No Change |
|
| week 24 Worse |
|
| week 24 Missing |
|
| week 12 Marked Response |
|
| week 12 Moderate Response |
|
| week 12 Slight Response |
|
| week 12 No Response |
|
| week 12 Worsening |
|
| week 12 Missing |
|
| week 24 Complete Response |
|
| week 24 Almost Complete Response |
|
| week 24 Marked Response |
|
| week 24 Moderate Response |
|
| week 24 Slight Response |
|
| week 24 No Response |
|
| week 24 Worsening |
|
| week 24 Missing |
|