Incidence of Adverse Events to Evaluate Long Term Safety Data
| Group | Value (participants) |
|---|---|
| All Subjects | 265 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited States, Argentina, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)
1 trial · 1 completed · 1 with posted results
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
NCT0179479310 Jun 2013 to 25 Jul 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.
Experimental
Pasireotide subcutaneous
0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.
Experimental
Pasireotide Long Acting Release (LAR)
10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Outcomes the sponsor listed as primary.
Incidence of Adverse Events to Evaluate Long Term Safety Data
Time frame · Baseline up to approximately 10 years
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Percentage of Patients With Clinical Benefit as Assessed by the Investigator
Time frame · Baseline up to approximately 10 years
Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| All Subjects | 265 |
| Group | Value (Participants) |
|---|---|
| Pasireotide Subcutaneous | 29 |
| Pasireotide Long Acting Release (LAR) | 256 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| All SubjectsPatients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis | 8 / 337 | 91 / 337 | 220 / 337 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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