Cushings Disease
Conditions
Keywords
Cushing's disease,, pasireotide s.c., Signifor
Brief summary
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.
Interventions
DRUGPasireotide
Sponsors
RECORDATI GROUP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data * Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option * Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry
Exclusion criteria
* Patients with ectopic ACTH-dependent Cushing's syndrome * Patients with adrenal Cushing's syndrome * Patients with Pseudo Cushing's syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | 3-year follow-up | Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease |
Countries
Canada, Colombia, France, Germany, Israel, Italy, Lebanon, Netherlands, Romania, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies. | 152 |
| Total | 152 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 13.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 126 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 118 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 148 |
| other Total, other adverse events | 132 / 148 |
| serious Total, serious adverse events | 49 / 148 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease
Time frame: 3-year follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1/New Use Cohort | Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | At least 1 treatment-emergent SAE that was suspected to be pasireotide-related. | 11 Participants |
| Cohort 1/New Use Cohort | Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | A treatment-emergent AE of any grade that was suspected to be pasireotide-related. | 34 Participants |
| Cohort 2/Prior Use Cohort | Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | At least 1 treatment-emergent SAE that was suspected to be pasireotide-related. | 13 Participants |
| Cohort 2/Prior Use Cohort | Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | A treatment-emergent AE of any grade that was suspected to be pasireotide-related. | 54 Participants |