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| ID | Type | Description | Link |
|---|---|---|---|
| B1801081 | Other Identifier | Alias Study Number |
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This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Patients with moderate to severe plaque psoriasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept (Enbrel®) | Drug | The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Drug-Free Interval Prior to Treatment Cycle 2 | Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Cycle 1 Week 24 up to Cycle 2 Week 0 |
| Duration of Drug-Free Interval Prior to Treatment Cycle 3 | Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Cycle 2 Week 24 up to Cycle 3 Week 0 |
| Duration of Drug-Free Interval Prior to Treatment Cycle 4 | Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Cycle 3 Week 24 up to Cycle 4 Week 0 |
| Duration of Drug-Free Interval Prior to Treatment Cycle 5 | Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe plaque psoriasis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27297981 | Derived | Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Loschmann PA. An observational study to evaluate the long-term outcomes of treatment with etanercept in patients with plaque-type psoriasis. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1730-1741. doi: 10.1111/jdv.13673. Epub 2016 Jun 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 955 participants were enrolled for documentation. Of these 955 participants enrolled, only 926 participants were included in analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety analysis set included all participants with available post-baseline safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only 915 participants had data available for age. |
| 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 | Duration of Drug-Free Interval Prior to Treatment Cycle 2 | Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed)= participants evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | weeks | Cycle 1 Week 24 up to Cycle 2 Week 0 |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Cycle 4 Week 24 up to Cycle 5 Week 0 |
| Duration of Drug-Free Interval Prior to Treatment Cycle 6 | Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Cycle 5 Week 24 up to Cycle 6 Week 0 |
| Week 0, 12, 24 of Cycle 1 to 6 |
| Percentage of Body Surface Area (BSA) Affected by Psoriasis | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis. | Week 0, 12, 24 of Cycle 1 to 6 |
| Static Physician Global Assessment (sPGA) of Disease Activity | Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions. | Week 0, 12, 24 of Cycle 1 to 6 |
| Physician Global Assessment of Efficacy | Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. | Week 24 of Cycle 1 to 6 |
| Patient Global Assessment of Efficacy | Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. | Week 24 of Cycle 1 to 6 |
| Number of Injections Per Year | Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Year 1, 2, 3, 4, 5 |
| Cumulative Dose of Etanercept Per Year | Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Year 1, 2, 3, 4, 5 |
| Percentage of Time on Treatment in First Year | Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1. | Year 1 |
| Percentage of Time on Treatment Over Entire Period | Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1). | Cycle 1 up to Cycle 6 |
| Patient's Global Assessment of Disease Activity (PatGA) | Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. | Week 0, 12, 24 of Cycle 1 to 6 |
| Dermatology Life Quality Index (DLQI) Score | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Week 0, 12, 24 of Cycle 1 to 6 |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. | Week 0, 12, 24 of Cycle 1 to 6 |
| Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state. | Week 0, 12, 24 of Cycle 1 to 6 |
| Number of Participants With at Least 1 Concomitant Medication | Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported. | Cycle 1 Week 0 up to Cycle 6 Week 24 |
| Annual Costs for Treatment With Etanercept | Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. | Year 1, 2, 3, 4, 5 |
| Average Cost of Treatment by Disease Severity | Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Year 1, 2, 3, 4, 5 |
| Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. | Prior to study, Year 1, 2, 3, 4, 5 |
| Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA) | Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. | Week 0, 12, 24 of Cycle 1 to 6 |
| Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Effect of drug free interval on DLQI was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Week 0, 12, 24 of Cycle 1 to 6 |
| Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO) | Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. | Week 0, 12, 24 of Cycle 1 to 6 |
| Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How long do you expect the drug-free interval to last for?" After the drug-free interval participants were asked, "How long did the drug-free interval last?" Results are reported for participant's perception of the length of drug-free interval. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Reason for Returning to Practice | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "Why did you return to the practice today?" Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice. | Before Cycle 2, 3, 4, 5, 6 |
| Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "Do you basically like the idea of a drug-free interval?" After the drug-free interval participants were asked, "How did you like the current drug-free interval?" Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Duration | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the length of the current drug-free interval?" Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval. | Before Cycle 2, 3, 4, 5, 6 |
| Participant Perception of Drug-Free Interval: Relapse of Symptoms | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How much are you concerned about a relapse of symptoms?" After the drug-free interval participants were asked, "Were you concerned about a relapse of symptoms during the drug-free interval?" Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?" After the drug-free interval participants were asked, "To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?" Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Disease Activity | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the activity of your disease during the first half of the drug-free interval?" and "How would you assess the activity of your disease during the second half of the drug-free interval?" Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval. | Before Cycle 2, 3, 4, 5, 6 |
| Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How much were you satisfied with the condition of your skin during the first half of the drug-free interval?" and "How much were you satisfied with the condition of your skin during the second half of the drug-free interval?" Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval. | Before Cycle 2, 3, 4, 5, 6 |
| Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval reduces the risk for adverse drug reactions." Results are reported for participant's perception of risk of adverse drug reactions. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Reminder of Disease | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "During drug-free interval I will not be reminded permanently of my disease." Results are reported for participant's perception of reminder of disease during the drug-free interval. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Comfort in Everyday Life | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval means more comfort in my everyday life." Results are reported for participant's perception of comfort of life during the drug-free interval. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "If possible, would you prefer a continuous therapy without drug-free interval?" Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Participant Perception of Drug-Free Interval: Recommendation of Therapy | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?" Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy. | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
| Criteria for Treatment Resumption | Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons. | Before Cycle 2, 3, 4, 5, 6 |
| Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Number of participants with AEs included participants affected with both SAEs and non-SAEs. | Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24) |
| Intolerance |
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| Another therapy along with Enbrel |
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| Other unspecified |
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| Good effectiveness |
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| Ineffectiveness (no systemic therapy) |
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| Administrative reasons |
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| Lack of effectiveness |
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| Lack of compliance |
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| Pregnancy |
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| Adverse Event |
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| Missing values |
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| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Number | participants |
|
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
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|
| Primary | Duration of Drug-Free Interval Prior to Treatment Cycle 3 | Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here 'N' (number of participants analyzed)= participants evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | weeks | Cycle 2 Week 24 up to Cycle 3 Week 0 |
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|
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| Primary | Duration of Drug-Free Interval Prior to Treatment Cycle 4 | Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | weeks | Cycle 3 Week 24 up to Cycle 4 Week 0 |
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| Primary | Duration of Drug-Free Interval Prior to Treatment Cycle 5 | Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | weeks | Cycle 4 Week 24 up to Cycle 5 Week 0 |
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| Primary | Duration of Drug-Free Interval Prior to Treatment Cycle 6 | Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | weeks | Cycle 5 Week 24 up to Cycle 6 Week 0 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Score | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | percentage of BSA | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Static Physician Global Assessment (sPGA) of Disease Activity | Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Physician Global Assessment of Efficacy | Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure. | Posted | Number | participants | Week 24 of Cycle 1 to 6 |
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| Secondary | Patient Global Assessment of Efficacy | Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure. | Posted | Number | participants | Week 24 of Cycle 1 to 6 |
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| Secondary | Number of Injections Per Year | Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure. | Posted | Mean | Standard Deviation | injections | Year 1, 2, 3, 4, 5 |
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| Secondary | Cumulative Dose of Etanercept Per Year | Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure. | Posted | Mean | Standard Deviation | mg | Year 1, 2, 3, 4, 5 |
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| Secondary | Percentage of Time on Treatment in First Year | Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | percentage of first year | Year 1 |
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| Secondary | Percentage of Time on Treatment Over Entire Period | Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1). | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | percentage of entire treatment period | Cycle 1 up to Cycle 6 |
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| Secondary | Patient's Global Assessment of Disease Activity (PatGA) | Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. | Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Dermatology Life Quality Index (DLQI) Score | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Number of Participants With at Least 1 Concomitant Medication | Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported. | Safety analysis set included all participants with available post-baseline safety data. | Posted | Number | participants | Cycle 1 Week 0 up to Cycle 6 Week 24 |
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| Secondary | Annual Costs for Treatment With Etanercept | Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for this outcome measure. | Posted | Mean | Standard Deviation | Euros | Year 1, 2, 3, 4, 5 |
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| Secondary | Average Cost of Treatment by Disease Severity | Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for the given disease severities. | Posted | Mean | Standard Deviation | Euros | Year 1, 2, 3, 4, 5 |
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| Secondary | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for this outcome measure. | Posted | Mean | Standard Deviation | Euros | Prior to study, Year 1, 2, 3, 4, 5 |
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| Secondary | Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA) | Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. | Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Effect of drug free interval on DLQI was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'=number of participants evaluable at the specified time points for the given cycles. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO) | Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. | Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n'=number of participants evaluable at the specified time points for the given cycles. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 12, 24 of Cycle 1 to 6 |
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| Secondary | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How long do you expect the drug-free interval to last for?" After the drug-free interval participants were asked, "How long did the drug-free interval last?" Results are reported for participant's perception of the length of drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | months | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "Why did you return to the practice today?" Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Number | participants | Before Cycle 2, 3, 4, 5, 6 |
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| Secondary | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "Do you basically like the idea of a drug-free interval?" After the drug-free interval participants were asked, "How did you like the current drug-free interval?" Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Duration | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the length of the current drug-free interval?" Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6 |
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| Secondary | Participant Perception of Drug-Free Interval: Relapse of Symptoms | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How much are you concerned about a relapse of symptoms?" After the drug-free interval participants were asked, "Were you concerned about a relapse of symptoms during the drug-free interval?" Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?" After the drug-free interval participants were asked, "To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?" Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Disease Activity | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the activity of your disease during the first half of the drug-free interval?" and "How would you assess the activity of your disease during the second half of the drug-free interval?" Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6 |
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| Secondary | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How much were you satisfied with the condition of your skin during the first half of the drug-free interval?" and "How much were you satisfied with the condition of your skin during the second half of the drug-free interval?" Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6 |
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| Secondary | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval reduces the risk for adverse drug reactions." Results are reported for participant's perception of risk of adverse drug reactions. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Reminder of Disease | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "During drug-free interval I will not be reminded permanently of my disease." Results are reported for participant's perception of reminder of disease during the drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval means more comfort in my everyday life." Results are reported for participant's perception of comfort of life during the drug-free interval. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "If possible, would you prefer a continuous therapy without drug-free interval?" Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Number | participants | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Participant Perception of Drug-Free Interval: Recommendation of Therapy | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?" Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy. | Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points. | Posted | Number | participants | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 |
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| Secondary | Criteria for Treatment Resumption | Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons. | Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. | Posted | Number | participants | Before Cycle 2, 3, 4, 5, 6 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Number of participants with AEs included participants affected with both SAEs and non-SAEs. | Safety analysis set included all participants with available post-baseline safety data. | Posted | Number | participants | Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24) |
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| 59 |
| 926 |
| 230 |
| 926 |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Congestive cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Phimosis | Congenital, familial and genetic disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Drowning | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Chronic tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Accident at work | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tuberculosis serology test positive | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Scrotal erythema | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal transplant | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Vascular graft | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| External ear inflammation | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Salivary gland enlargement | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rebound effect | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site dryness | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site recall reaction | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Accident at home | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Drug exposure before pregnancy | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Drug exposure via breast milk | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Recall phenomenon | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Blood count abnormal | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tuberculosis test positive | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Podagra | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dysplastic naevus syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Acne conglobata | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Alopecia effluvium | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dermatitis papillaris capillitii | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dermographism | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Photosensitivity allergic reaction | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Immobile | Social circumstances | MedDRA 11.1 | Non-systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Wart excision | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=435) |
|
| Cycle 2 Week 12 (n=394) |
|
| Cycle 2 Week 24 (n=368) |
|
| Cycle 3 Week 0 (n=234) |
|
| Cycle 3 Week 12 (n=226) |
|
| Cycle 3 Week 24 (n=202) |
|
| Cycle 4 Week 0 (n=120) |
|
| Cycle 4 Week 12 (n=117) |
|
| Cycle 4 Week 24 (n=105) |
|
| Cycle 5-week 0 (n=77) |
|
| Cycle 5 Week 12 (n=79) |
|
| Cycle 5 Week 24 (n=63) |
|
| Cycle 6 Week 0 (n=60) |
|
| Cycle 6 Week 12 (n=54) |
|
| Cycle 6 Week 24 (n=48) |
|
|
| Cycle 1 Week 24 (n=294,143,168) |
|
| Cycle 2 Week 0 (n=293,143,66) |
|
| Cycle 2 Week 12 (n=280,127,62) |
|
| Cycle 2 Week 24 (n=263,117,53) |
|
| Cycle 3 Week 0 (n=212,44,47) |
|
| Cycle 3 Week 12 (n=201,40,43) |
|
| Cycle 3 Week 24 (n=181,38,36) |
|
| Cycle 4 Week 0 (n=144,8,21) |
|
| Cycle 4 Week 12 (n=128,8,20) |
|
| Cycle 4 Week 24 (n=121,7,18) |
|
| Cycle 5 Week 0 (n=100,4,10) |
|
| Cycle 5 Week 12 (n=98,2,9) |
|
| Cycle 5 Week 24 (n=88,1,5) |
|
| Cycle 6 Week 0 (n=82,1,3) |
|
| Cycle 6 Week 12 (n=75,0,2) |
|
| Cycle 6 Week 24 (n=68,0,2) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=514) |
|
| Cycle 2 Week 12 (n=482) |
|
| Cycle 2 Week 24 (n=444) |
|
| Cycle 3 Week 0 (n=307) |
|
| Cycle 3 Week 12 (n=291) |
|
| Cycle 3 Week 24 (n=259) |
|
| Cycle 4 Week 0 (n=174) |
|
| Cycle 4 Week 12 (n=158) |
|
| Cycle 4 Week 24 (n=147) |
|
| Cycle 5 Week 0 (n=114) |
|
| Cycle 5 Week 12 (n=109) |
|
| Cycle 5 Week 24 (n=95) |
|
| Cycle 6 Week 0 (n=88) |
|
| Cycle 6 Week 12 (n=78) |
|
| Cycle 6 Week 24 (n=71) |
|
| Title | Measurements |
|---|---|
|
| Cycle 1: insufficient (n=606) |
|
| Cycle 2: very good (n=440) |
|
| Cycle 2: good (n=440) |
|
| Cycle 2: moderate (n=440) |
|
| Cycle 2: insufficient (n=440) |
|
| Cycle 3: very good (n=259) |
|
| Cycle 3: good (n=259) |
|
| Cycle 3: moderate (n=259) |
|
| Cycle 3: insufficient (n=259) |
|
| Cycle 4: very good (n=147) |
|
| Cycle 4: good (n=147) |
|
| Cycle 4: moderate (n=147) |
|
| Cycle 4: insufficient (n=147) |
|
| Cycle 5: very good (n=96) |
|
| Cycle 5: good (n=96) |
|
| Cycle 5: moderate (n=96) |
|
| Cycle 5: insufficient (n=96) |
|
| Cycle 6: very good (n=70) |
|
| Cycle 6: good (n=70) |
|
| Cycle 6: moderate (n=70) |
|
| Cycle 6: insufficient (n=70) |
|
| Title | Measurements |
|---|---|
|
| Cycle 1: insufficient (n=605) |
|
| Cycle 2: very good (n=444) |
|
| Cycle 2: good (n=444) |
|
| Cycle 2: moderate (n=444) |
|
| Cycle 2: insufficient (n=444) |
|
| Cycle 3: very good (n=258) |
|
| Cycle 3: good (n=258) |
|
| Cycle 3: moderate (n=258) |
|
| Cycle 3: insufficient (n=258) |
|
| Cycle 4: very good (n=147) |
|
| Cycle 4: good (n=147) |
|
| Cycle 4: moderate (n=147) |
|
| Cycle 4: insufficient (n=147) |
|
| Cycle 5: very good (n=96) |
|
| Cycle 5: good (n=96) |
|
| Cycle 5: moderate (n=96) |
|
| Cycle 5: insufficient (n=96) |
|
| Cycle 6: very good (n=71) |
|
| Cycle 6: good (n=71) |
|
| Cycle 6: moderate (n=71) |
|
| Cycle 6: insufficient (n=71) |
|
| Title | Measurements |
|---|---|
|
| Year 4 (n=53) |
|
| Year 5 (n=7) |
|
| Title | Measurements |
|---|---|
|
| Year 4 (n=53) |
|
| Year 5 (n=7) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=349) |
|
| Cycle 2 Week 12 (n=455) |
|
| Cycle 2 Week 24 (n=395) |
|
| Cycle 3 Week 0 (n=191) |
|
| Cycle 3 Week 12 (n=261) |
|
| Cycle 3 Week 24 (n=224) |
|
| Cycle 4 Week 0 (n=89) |
|
| Cycle 4 Week 12 (n=145) |
|
| Cycle 4 Week 24 (n=132) |
|
| Cycle 5 Week 0 (n=63) |
|
| Cycle 5 Week 12 (n=103) |
|
| Cycle 5 Week 24 (n=92) |
|
| Cycle 6 Week 0 (n=43) |
|
| Cycle 6 Week 12 (n=76) |
|
| Cycle 6 Week 24 (n=68) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=334) |
|
| Cycle 2 Week 12 (n=440) |
|
| Cycle 2 Week 24 (n=378) |
|
| Cycle 3 Week 0 (n=186) |
|
| Cycle 3 Week 12 (n= 258) |
|
| Cycle 3 Week 24 (n=221) |
|
| Cycle 4 Week 0 (n=90) |
|
| Cycle 4 Week 12 (n=146) |
|
| Cycle 4 Week 24 (n=132) |
|
| Cycle 5 Week 0 (n=64) |
|
| Cycle 5 Week 12 (n=104) |
|
| Cycle 5 Week 24 (n=91) |
|
| Cycle 6 Week 0 (n=43) |
|
| Cycle 6 Week 12 (n=75) |
|
| Cycle 6 Week 24 (n=69) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=344) |
|
| Cycle 2 Week 12 (n=451) |
|
| Cycle 2 Week 24 (n=393) |
|
| Cycle 3 Week 0 (n=190) |
|
| Cycle 3 Week 12 (n= 257) |
|
| Cycle 3 Week 24 (n=222) |
|
| Cycle 4 Week 0 (n=89) |
|
| Cycle 4 Week 12 (n=144) |
|
| Cycle 4 Week 24 (n=129) |
|
| Cycle 5 Week 0 (n=63) |
|
| Cycle 5 Week 12 (n=104) |
|
| Cycle 5 Week 24 (n=91) |
|
| Cycle 6 Week 0 (n=43) |
|
| Cycle 6 Week 12 (n=75) |
|
| Cycle 6 Week 24 (n=69) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Week 0 (n=344) |
|
| Cycle 2 Week 12 (n=451) |
|
| Cycle 2 Week 24 (n=393) |
|
| Cycle 3 Week 0 (n=190) |
|
| Cycle 3 Week 12 (n= 257) |
|
| Cycle 3 Week 24 (n=222) |
|
| Cycle 4 Week 0 (n=89) |
|
| Cycle 4 Week 12 (n=144) |
|
| Cycle 4 Week 24 (n=129) |
|
| Cycle 5 Week 0 (n=63) |
|
| Cycle 5 Week 12 (n=104) |
|
| Cycle 5 Week 24 (n=91) |
|
| Cycle 6 Week 0 (n=43) |
|
| Cycle 6 Week 12 (n=75) |
|
| Cycle 6 Week 24 (n=69) |
|
| Title | Measurements |
|---|---|
|
| Year 4 (n=53) |
|
| Year 5 (n=7) |
|
| Title | Measurements |
|---|---|
|
| Year 2: Mild (n=200) |
|
| Year 2: Moderate (n=32) |
|
| Year 2: Severe (n=9) |
|
| Year 3: Mild (n=93) |
|
| Year 3: Moderate (n=3) |
|
| Year 3: Severe (n=4) |
|
| Year 4: Mild (n=25) |
|
| Year 4: Moderate (n=1) |
|
| Year 4: Severe (n=2) |
|
| Year 5: Mild (n=6) |
|
| Title | Measurements |
|---|---|
|
| Year 3 (n=131) |
|
| Year 4 (n=44) |
|
| Year 5 (n=6) |
|
| Cycle 1 Week 24 (n=274, 139) |
|
| Cycle 2 Week 0 (n=156, 136) |
|
| Cycle 2 Week 12 (n=264, 130) |
|
| Cycle 2 Week 24 (n=238, 111) |
|
| Cycle 3 Week 0 (n=112, 41) |
|
| Cycle 3 Week 12 (n=184, 38) |
|
| Cycle 3 Week 24 (n=161, 36) |
|
| Cycle 4 Week 0 (n=71, 6) |
|
| Cycle 4 Week 12 (n=123, 6) |
|
| Cycle 4 Week 24 (n=112, 5) |
|
| Cycle 5 Week 0 (n=53, 2) |
|
| Cycle 5 Week 12 (n=94, 2) |
|
| Cycle 5 Week 24 (n=84, 2) |
|
| Cycle 6 Week 0 (n=39, 2) |
|
| Cycle 6 Week 12 (n=73 1) |
|
| Cycle 6 Week 24(n=66, 0) |
|
| Cycle 1 Week 24 (n=263,135) |
|
| Cycle 2 Week 0 (n=145,133) |
|
| Cycle 2 Week 12 (n=256,128) |
|
| Cycle 2 Week 24 (n=227,107) |
|
| Cycle 3 Week 0 (n=109,41) |
|
| Cycle 3 Week 12 (n= 183,38) |
|
| Cycle 3 Week 24 (n=158,36) |
|
| Cycle 4 Week 0 (n=72,6) |
|
| Cycle 4 Week 12 (n=124,6) |
|
| Cycle 4 Week 24 (n=112,5) |
|
| Cycle 5 Week 0 (n=53,3) |
|
| Cycle 5 Week 12 (n=94,2) |
|
| Cycle 5 Week 24 (n=83,2) |
|
| Cycle 6 Week 0 (n=39,2) |
|
| Cycle 6 Week 12 (n=72,1) |
|
| Cycle 6 Week 24 (n=67,0) |
|
| Cycle 1 Week 24 (n=272,139) |
|
| Cycle 2 Week 0 (n=152,135) |
|
| Cycle 2 Week 12 (n=261,129) |
|
| Cycle 2 Week 24 (n=238,111) |
|
| Cycle 3 Week 0 (n=111,41) |
|
| Cycle 3 Week 12 (n= 181,37) |
|
| Cycle 3 Week 24 (n=160,35) |
|
| Cycle 4 Week 0 (n=71,6) |
|
| Cycle 4 Week 12 (n=122,6) |
|
| Cycle 4 Week 24 (n=110,5) |
|
| Cycle 5 Week 0 (n=53,2) |
|
| Cycle 5 Week 12 (n=94,2) |
|
| Cycle 5 Week 24 (n=83,2) |
|
| Cycle 6 Week 0 (n=39,2) |
|
| Cycle 6 Week 12 (n=72,1) |
|
| Cycle 6 Week 24 (n=67,0) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=37) |
|
| After Cycle 3 (n=2) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=0) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=0) |
|
| Before Cycle 6 (n=1) |
|
|
| Before Cycle 3- unscheduled visit (n=43) |
|
| Before Cycle 3- scheduled visit (n=43) |
|
| Before Cycle 3- other reason (n=43) |
|
| Before Cycle 4- unscheduled visit(n=7) |
|
| Before Cycle 4- scheduled visit (n=7) |
|
| Before Cycle 4-other reason (n=7) |
|
| Before Cycle 5- unscheduled visit(n=1) |
|
| Before Cycle 5-scheduled visit (n=1) |
|
| Before Cycle 5-other reason (n=1) |
|
| Before Cycle 6- unscheduled visit (n=1) |
|
| Before Cycle 6-scheduled visit (n=1) |
|
| Before Cycle 6-other reason (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=37) |
|
| After Cycle 3 (n=7) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=2) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=36) |
|
| After Cycle 3 (n=7) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=3) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=35) |
|
| After Cycle 3 (n=6) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=2) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
|
| Before Cycle 3-second half (n=36) |
|
| Before Cycle 4-first half (n=4) |
|
| Before Cycle 4-second half (n=4) |
|
| Before Cycle 5-first half (n=1) |
|
| Before Cycle 5-second half (n=1) |
|
| Before Cycle 6-first half (n=1) |
|
| Before Cycle 6-second half (n=1) |
|
|
| Before Cycle 3-second half (n=36) |
|
| Before Cycle 4-first half (n=4) |
|
| Before Cycle 4-second half (n=4) |
|
| Before Cycle 5-first half (n=1) |
|
| Before Cycle 5-second half (n=1) |
|
| Before Cycle 6-first half (n=1) |
|
| Before Cycle 6-second half (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=38) |
|
| After Cycle 3 (n=6) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=1) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=38) |
|
| After Cycle 3 (n=5) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=3) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 3 (n=38) |
|
| After Cycle 3 (n=5) |
|
| Before Cycle 4 (n=5) |
|
| After Cycle 4 (n=3) |
|
| Before Cycle 5 (n=1) |
|
| After Cycle 5 (n=1) |
|
| Before Cycle 6 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 2- Yes (n=106) |
|
| After Cycle 2- No (n=40) |
|
| After Cycle 2- Yes (n=40) |
|
| Before Cycle 3- No (n=42) |
|
| Before Cycle 3- Yes (n=42) |
|
| After Cycle 3- No (n=7) |
|
| After Cycle 3- Yes (n=7) |
|
| Before Cycle 4- No (n=6) |
|
| Before Cycle 4- Yes (n=6) |
|
| After Cycle 4- No (n=3) |
|
| After Cycle 4- Yes (n=3) |
|
| Before Cycle 5- No (n=1) |
|
| Before Cycle 5- Yes (n=1) |
|
| After Cycle 5- No (n=1) |
|
| After Cycle 5- Yes (n=1) |
|
| Before Cycle 6- No (n=1) |
|
| Before Cycle 6- Yes (n=1) |
|
| Title | Measurements |
|---|---|
|
| Before Cycle 2- Yes (n=107) |
|
| After Cycle 2- No (n=40) |
|
| After Cycle 2- Yes (n=40) |
|
| Before Cycle 3- No (n=42) |
|
| Before Cycle 3- Yes (n=42) |
|
| After Cycle 3- No (n=7) |
|
| After Cycle 3- Yes (n=7) |
|
| After Cycle 4- No (n=1) |
|
| After Cycle 4- Yes (n=1) |
|
|
| Before Cycle 2- NDA and POD (n=144) |
|
| Before Cycle 2- NDA and other reason (n=144) |
|
| Before Cycle 2- POD and other reason (n=144) |
|
| Before Cycle 2- NDA, POD and other reason (n=144) |
|
| Before Cycle 3-NDA (n=43) |
|
| Before Cycle 3- POD (n=43) |
|
| Before Cycle 3- other reason (n=43) |
|
| Before Cycle 3- NDA and POD (n=43) |
|
| Before Cycle 3- NDA and other reason (n=43) |
|
| Before Cycle 3- POD and other reason (n=43) |
|
| Before Cycle 3- NDA, POD and other reason (n=43) |
|
| Before Cycle 4- NDA (n=8) |
|
| Before Cycle 4- POD (n=8) |
|
| Before Cycle 4- other reason (n=8) |
|
| Before Cycle 4- NDA and POD (n=8) |
|
| Before Cycle 4- NDA and other reason (n=8) |
|
| Before Cycle 4- POD and other reason (n=8) |
|
| Before Cycle 4-NDA, POD and other reason (n=8) |
|
| Before Cycle 5- NDA (n=3) |
|
| Before Cycle 5- POD (n=3) |
|
| Before Cycle 5- other reason (n=3) |
|
| Before Cycle 5- NDA and POD (n=3) |
|
| Before Cycle 5- NDA and other reason (n=3) |
|
| Before Cycle 5- POD and other reason (n=3) |
|
| Before Cycle 5- NDA, POD and other reason (n=3) |
|
| Before Cycle 6- NDA (n=1) |
|
| Before Cycle 6- POD (n=1) |
|
| Before Cycle 6- other reason (n=1) |
|
| Before Cycle 6- NDA and POD (n=1) |
|
| Before Cycle 6- NDA and other reason (n=1) |
|
| Before Cycle 6- POD and other reason (n=1) |
|
| Before Cycle 6- NDA, POD and other reason (n=1) |
|