An observational study in Parkinson's Disease and Hyperprolactinemia, sponsored by Pfizer. Completed. Per ClinicalTrials.gov, last updated 2014-05-02.
Sponsored by Pfizer · Observational
The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.
Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis
does not involve random selection
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 22,014 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cohort of patients, who are treated with cabergoline during the study period. This cohort will be divided in new users and prevalent users based on when cabergoline was started. New (incident) users will be all persons who have a first prescription for cabergoline after the date that the change in SPC was made. Prevalent users will be all cohort members who received a cabergoline prescription during the study period but who had also been using cabergoline prior to the change in SPC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
Drug: Study Drug
non interventional study - usage as per usual care
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 1 (Year 2006)
Number of Cabergoline Prescriptions by Database and Indication: Year 2
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 2 (Year 2007)
Number of Cabergoline Prescriptions by Database and Indication: Year 3
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 3 (Year 2008)
Number of Cabergoline Prescriptions by Database and Indication: Year 4
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 4 (Year 2009)
Number of Cabergoline Prescriptions by Database and Indication: Year 5
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 5 (Year 2010)
Number of Cabergoline Prescriptions by Database and Indication: Year 6
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 6 (Year 2011)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 1 (Year 2006)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 2 (Year 2007)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 3 (Year 2008)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 4 (Year 2009)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 5 (Year 2010)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 6 (Year 2011)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 1 (Year 2006)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 2 (Year 2007)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 3 (Year 2008)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 4 (Year 2009)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 5 (Year 2010)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 6 (Year 2011)
Total Number of Echocardiography Examinations in Cabergoline Users
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
Time frame: Baseline (Week 1) up to Week 339
Incidence of Valvular Fibrosis
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
Time frame: Baseline (Week 1) up to Week 339
Prevalence of Valvular Fibrosis
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
Time frame: Baseline (Week 1) up to Week 339
Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy.
| Milestone | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|---|---|---|---|---|
| Started | 7537 | 6580 | 326 | 5486 | 2024 | 0 | 0 | 0 |
| Completed | 7537 | 6580 | 326 | 5486 | 2024 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 11 | 2 | 48 |
| Completed | 0 | 0 | 0 | 0 | 0 | 11 | 2 | 48 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 17 | 1782 | 6 | 293 | 198 |
| N04BC06 | 87 | 1483 | 0 | 0 | 577 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 1925 | 3616 | 64 | 2698 | 3537 |
| N04BC06 | 741 | 2139 | 0 | 0 | 3325 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 2098 | 3493 | 152 | 2621 | 3556 |
| N04BC06 | 507 | 807 | 0 | 0 | 1656 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 2260 | 3629 | 226 | 2684 | 3240 |
| N04BC06 | 306 | 463 | 0 | 0 | 1119 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 2395 | 3793 | 283 | 2752 | 3170 |
| N04BC06 | 201 | 274 | 0 | 0 | 981 |
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
| prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| G02CB03 | 2286 | 3686 | 183 | 2660 | 3212 |
| N04BC06 | 141 | 143 | 0 | 0 | 859 |
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | 0 | 0 | 0 |
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | 4 | 10 | 10 |
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | 20 | 39 | 23 |
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | 7 | 22 | 12 |
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | 18 | 43 | 21 |
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | 11 | 67 | 0 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 0 | 5 | 0 | 0 | 17 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 0.2 | 5 | 2 | 0 | 13 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 0 | 3 | 5 | 0 | 7 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 0 | 2 | 1 | 0 | 5 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 0 | 3 | 1 | 0 | 2 |
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
| percentage of prescriptions | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 0 | 1 | 0 | 0 | 2 |
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
| echocardiography examinations | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Total Number of Echocardiography Examinations in Cabergoline Users | 11 | 3 | 68 |
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
| percentage of participants | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Incidence of Valvular Fibrosis | 100 | 0 | 57.1 |
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
| percentage of participants | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Prevalence of Valvular Fibrosis | 57.2 | 50.0 | 55.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aarhus [Part 1] | — | — | — |
| HSD [Part 1] | — | — | — |
| IPCI [Part 1] | — | — | — |
| PHARMO [Part 1] | — | — | — |
| THIN [Part 1] | — | — | — |
| Cabergoline in Pre-SPC Change Period [Part 2] | — | — | — |
| Cabergoline in Post- SPC Change Period [Part 2] | — | — | — |
| Cabergoline in Cross-SPC Change Period [Part 2] | — | — | — |
Study population included all participants who were treated with cabergoline, registered in one of the databases and those recruited from specialized clinical centers in Italy for Parkinson\’s disease during the study period.
| Age, Customized(years) | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | Total |
|---|---|---|---|---|---|---|---|---|---|
| Part 1, Compliance: G02CB03 | 33.6 ± 10.7 | 39.0 ± 12.3 | 42.1 ± 14.0 | 41.3 ± 15.8 | 47.1 ± 16.2 | NA ± NA | NA ± NA | NA ± NA | 40.8 ± 14.8 |
| Part 1, Compliance: N04BC06 | 66.4 ± 13.2 | 73.1 ± 11.3 | NA ± NA | NA ± NA | 69.7 ± 13.6 | NA ± NA | NA ± NA | NA ± NA | 70.4 ± 13.0 |
| Part 2, Effectiveness | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA | 62.7 ± 5.6 | 58.7 ± 8.5 | 63.7 ± 13.9 | 63.3 ± 12.5 |
| Sex: Female, Male(Participants) | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 7429 | 6180 | 288 | 5180 | 1468 | 2 | 0 | 13 | 20560 |
| Male | 108 | 400 | 38 | 306 | 556 | 9 | 2 | 35 | 1454 |
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