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This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Experimental | Participants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Drug | Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF | Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF). | Baseline, Month 12 LOCF |
| Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | At Month 6 |
| Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | At Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Tolerability Assessment For Erythema | Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoebe Rich, MD | Portland | Oregon | 97210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12963896 | Background | Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x. |
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A total of 452 participants were enrolled at 28 study centers in the United States from 17 February 2004 to 23 May 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene/Benzoyl Peroxide | Participants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5% (W/W) gel topically to the face and trunk area as applicable once daily in the evening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The intent-to-treat (ITT) population included all participants who were enrolled and to whom medication was dispensed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene/Benzoyl Peroxide | Participants were treated with adapalene 0.1 % (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area as applicable once daily in the evening. |
| 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 | Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF | Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF). | ITT population included all participants who were enrolled and treated to whom medication was dispensed. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 12 LOCF |
|
Baseline up to 14 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 | Adapalene/Benzoyl Peroxide | Participants were treated with adapalene 0.1 % (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and truck area, as applicable, once daily in the evening. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Depression | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
| Number of Participants With Local Tolerability Assessment For Scaling | Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
| Number of Participants With Local Tolerability Assessment For Dryness | Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
| Number of Participants With Local Tolerability Assessment For Stinging/Burning | Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
| Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Month 14 |
| Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. | Baseline up to Month 14 |
| Lost to Follow-up |
|
| Pregnancy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| Adapalene/Benzoyl Peroxide |
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening. |
|
|
| Primary | Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | ITT population included all participants who were enrolled and to whom medication was dispensed. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Month 6 |
|
|
|
| Primary | Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | ITT population included all participants who were enrolled and to whom medication was dispensed. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Month 12 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Assessment For Erythema | Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe. | The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint. | Posted | Count of Participants | Participants | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Assessment For Scaling | Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production). | The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint. | Posted | Count of Participants | Participants | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Assessment For Dryness | Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness). | The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint. | Posted | Count of Participants | Participants | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
|
|
|
| Secondary | Number of Participants With Local Tolerability Assessment For Stinging/Burning | Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort). | ITT safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint. | Posted | Count of Participants | Participants | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 |
|
|
|
| Secondary | Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety population was defined as all participants enrolled who had applied study medication at least once. | Posted | Count of Participants | Participants | Baseline up to Month 14 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. | The safety population was defined as all participants enrolled who had applied study medication at least once. | Posted | Count of Participants | Participants | Baseline up to Month 14 |
|
|
|
| 0 |
| 452 |
| 5 |
| 452 |
| 288 |
| 452 |
| Bipolar Disorder | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Drug Abuser | Social circumstances | MedDRA (6.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Herpes Simplex | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Otitis Externa | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Gingival Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Vaginal Mycosis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Tinea Pedis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Body Tinea | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Nail Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Helicobacter Gastritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Eye Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Conjunctivitis Infective | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Abdominal Infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Desquamation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Discomfort | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermatitis Exfoliative | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Acne Cystic | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pain of Skin | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Heat Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Face Odema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application Site Burning | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Application Site Irritation | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Fatique | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Post Procedural Pain | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Tendon Injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Chemical Injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Tooth Injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Nasal Conjection | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Nasal Odema | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Rhitinis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Allergic Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastrointestinal Upset | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Attention Deficit/Hyperactivity Disorder | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Drug Dependence | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Stress Symptoms | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Tendon Disorder | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Laboratory Test Abnormal | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Mean Cell Hemoglobin Decreased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Heart Rate Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Haemoglobin Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Haematocrit Increased | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Haematocrit Decreased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Protein Urine Present | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Platelet Count Abnormal | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Mean Cell Volume Abnormal | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Ovarian Cyst Ruptured | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Food Allergy | Immune system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
|
| Seborrhoeic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
|
| Dysplastic Naevus Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Ear Discomfort | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Tympanic Membrane Perforation | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Eyelid Oedema | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Myopia | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Eye Discharge | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Calcus Urinary | Renal and urinary disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000068816 | Adapalene |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| 3=Minimal Improvement |
|
| 4=No Change |
|
| 5=Worse |
|
| 3=Minimal Improvement |
|
| 4=No Change |
|
| 5=Worse |
|
| 2=Moderate |
|
| 3=Severe |
|
| Week 1 |
|
|
| Week 2 |
|
|
| Month 1 |
|
|
| Month 2 |
|
|
| Month 4 |
|
|
| Month 6 |
|
|
| Month 8 |
|
|
| Month 10 |
|
|
| Month 12 |
|
|
| 2=Moderate |
|
| 3=Severe |
|
| Week 1 |
|
|
| Week 2 |
|
|
| Month 1 |
|
|
| Month 2 |
|
|
| Month 4 |
|
|
| Month 6 |
|
|
| Month 8 |
|
|
| Month 10 |
|
|
| Month 12 |
|
|
| 2=Moderate |
|
| 3=Severe |
|
| Week 1 |
|
|
| Week 2 |
|
|
| Month 1 |
|
|
| Month 2 |
|
|
| Month 4 |
|
|
| Month 6 |
|
|
| Month 8 |
|
|
| Month 10 |
|
|
| Month 12 |
|
|
| 2=Moderate |
|
| 3=Severe |
|
| Week 1 |
|
|
| Week 2 |
|
|
| Month 1 |
|
|
| Month 2 |
|
|
| Month 4 |
|
|
| Month 6 |
|
|
| Month 8 |
|
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| Month 10 |
|
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| Month 12 |
|
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| Title | Measurements |
|---|---|
|