Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIRCERA Ready-To-Use-Syringe | Participants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram [mcg/kg]) every 2 weeks (q2w) up to 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIRCERA | Device | Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered. | Baseline |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 1 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 2 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 3 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentration | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
N/A
Not provided
Not provided
Not provided
Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daun | 54550 | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MIRCERA | Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set included all participants who had at least one MIRCERA application.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MIRCERA | Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered. | Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA. | Posted | Number | percentage of participants | Baseline |
|
up to the end of study (9 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIRCERA | Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
Not provided
Not provided
Not provided
| Month 4 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 5 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 6 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 7 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 8 |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Month 9 |
| Change From Baseline in Pain Sensation Using Visual Analogue Scale | Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application. | Baseline, Months 1-9 |
| Percentage of Participants Who Reported Easement of Therapy With MIRCERA | 9 months |
| Percentage of Participants Who Continued Treatment After End of Study | End of observation period (Month 9) |
| Average Monthly Dose of MIRCERA | 9 months |
| Number of MIRCERA Dose Adaptations | 9 months |
| Mean Monthly Administrations of MIRCERA | 9 months |
| Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Lack of Efficacy |
|
| Consent withdrawn |
|
| Enrolled but not treated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. | Posted | Number | percentage of participants | Month 1 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 2 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 3 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were available for this outcome measure. | Posted | Number | percentage of participants | Month 4 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 5 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 7 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 8 |
|
|
|
| Primary | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Month 9 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin (Hb) Concentration | Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe. | Posted | Mean | Standard Deviation | g/dL | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
|
|
|
| Primary | Change From Baseline in Pain Sensation Using Visual Analogue Scale | Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application. | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1-9 |
|
|
|
| Primary | Percentage of Participants Who Reported Easement of Therapy With MIRCERA | Participant Satisfaction Set. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Primary | Percentage of Participants Who Continued Treatment After End of Study | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | End of observation period (Month 9) |
|
|
|
| Primary | Average Monthly Dose of MIRCERA | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | grams | 9 months |
|
|
|
| Primary | Number of MIRCERA Dose Adaptations | Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | dose adaptations | 9 months |
|
|
|
| Primary | Mean Monthly Administrations of MIRCERA | Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | MIRCERA administrations per month | 9 months |
|
|
|
| Primary | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit. | Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe. | Posted | Number | percentage of participants | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
|
|
|
| 27 |
| 238 |
| 9 |
| 238 |
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Arteriovenous shunt operation | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Storage |
|
| Disposal |
|
| Title | Measurements |
|---|---|
|
| Month 4 (n = 165) |
|
| Month 5 (n = 161) |
|
| Month 6 (n = 152) |
|
| Month 7 (n = 171) |
|
| Month 8 (n = 159) |
|
| Month 9 (n = 86) |
|
| Title | Measurements |
|---|---|
|
| Month 1: 1 (n=221) |
|
| Month 1: 2 (n=221) |
|
| Month 1: No satisfaction rating (n=221) |
|
| Month 2: -2 (n=218) |
|
| Month 2: -1 (n=218) |
|
| Month 2: 0 (n=218) |
|
| Month 2: 1 (n=218) |
|
| Month 2: 2 (n=218) |
|
| Month 2: No satisfaction rating (n=218) |
|
| Month 3: -2 (n=213) |
|
| Month 3: -1 (n=213) |
|
| Month 3: 0 (n=213) |
|
| Month 3: 1 (n=213) |
|
| Month 3: 2 (n=213) |
|
| Month 3: No satisfaction rating (n=213) |
|
| Month 4: -2 (n=210) |
|
| Month 4: -1 (n=210) |
|
| Month 4: 0 (n=210) |
|
| Month 4: 1 |
|
| Month 4: 2 (n=210) |
|
| Month 4: No satisfaction rating (n=210) |
|
| Month 5: -2 (n=204) |
|
| Month 5: -1 (n=204) |
|
| Month 5: 0 (n=204) |
|
| Month 5: 1 (n=204) |
|
| Month 5: 2 (n=204) |
|
| Month 5: No satisfaction rating (n=204) |
|
| Month 6: -2 (n=197) |
|
| Month 6: -1 (n=197) |
|
| Month 6: 0 (n=197) |
|
| Month 6: 1 (n=197) |
|
| Month 6: 2 (n=197) |
|
| Month 6: No satisfaction rating (n=197) |
|
| Month 7: -2 (n=192) |
|
| Month 7: -1 (n=192) |
|
| Month 7: 0 (n=192) |
|
| Month 7: 1 (n=192) |
|
| Month 7: 2 (n=192) |
|
| Month 7: No satisfaction rating (n=192) |
|
| Month 8: -2 (n=187) |
|
| Month 8: -1 (n=187) |
|
| Month 8: 0 (n=187) |
|
| Month 8: 1 (n=187) |
|
| Month 8: 2 (n=187) |
|
| Month 8: No satisfaction rating (n=187) |
|
| Month 9: -2 (n=183) |
|
| Month 9: -1 (n=183) |
|
| Month 9: 0 (n=183) |
|
| Month 9: 1 (n=183) |
|
| Month 9: 2 (n=183) |
|
| Month 9: No satisfaction rating (n=183) |
|