Trial Outcomes & Findings for Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease (NCT NCT02310269)
NCT ID: NCT02310269
Last Updated: 2024-10-15
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
152 participants
Primary outcome timeframe
3-year follow-up
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
All Subjects
Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies.
|
|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
123
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Baseline characteristics by cohort
| Measure |
All Subjects
n=152 Participants
Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies.
|
|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 13.64 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
126 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3-year follow-upNumber 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
Outcome measures
| Measure |
Cohort 1/New Use Cohort
n=43 Participants
Subjects who initiated pasireotide s.c. at time of study entry (on or after the signing of the informed consent or acknowledging an equivalent document -for example, written information- as per country regulation).
Pasireotide
|
Cohort 2/Prior Use Cohort
n=105 Participants
Subjects who initiated pasireotide s.c. prior to study entry.
Pasireotide
|
|---|---|---|
|
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
|
13 Participants
|
|
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
|
54 Participants
|
Adverse Events
All Subjects
Serious events: 49 serious events
Other events: 132 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
All Subjects
n=148 participants at risk
Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.1%
6/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.1%
6/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Cerebral haematoma
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Coma
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Headache
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Loss of consciousness
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Migraine
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Presyncope
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Syncope
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Pituitary-dependent Cushing's syndrome
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Hyperadrenocorticism
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Drug ineffective
|
2.7%
4/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
General physical health deterioration
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Asthenia
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Fatigue
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Malaise
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Pneumonia
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
COVID-19
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Meningitis haemophilus
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Nasopharyngitis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Pyonephrosis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Rhinitis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Soft tissue infection
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Cardiac arrest
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Coronary artery disease
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Cortisol increased
|
4.7%
7/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Hepatic enzyme increased
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
CSF test abnormal
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Cortisol free urine increased
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Grip strength decreased
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Transaminases increased
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Weight decreased
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.7%
4/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
2.0%
3/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary cancer metastatic
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Renal and urinary disorders
Calculus urinary
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
2/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Psychiatric disorders
Confusional state
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Psychiatric disorders
Mental status changes
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Vascular disorders
Hypertension
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Eye disorders
Visual impairment
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.68%
1/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
Other adverse events
| Measure |
All Subjects
n=148 participants at risk
Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
25.7%
38/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
23/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.8%
19/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hyperclycaemia
|
12.2%
18/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Asthenia
|
10.8%
16/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Fatigue
|
10.8%
16/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Headache
|
10.8%
16/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Adrenal Insuffiency
|
8.1%
12/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
11/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.4%
11/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Vascular disorders
Hypertension
|
7.4%
11/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Drug Ineffective
|
6.8%
10/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
10/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
9/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
9/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Dizziness
|
5.4%
8/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
8/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Endocrine disorders
Hyperadrenocorticism
|
4.7%
7/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
4.7%
7/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.1%
6/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
6/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Nervous system disorders
Vertigo
|
4.1%
6/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
3.4%
5/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.4%
5/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
General disorders
Feeling cold
|
2.7%
4/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
2.7%
4/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
|
Investigations
Weight decreased
|
2.7%
4/148 • Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Physician or Institution must submit to Sponsor at least 45 days before any publication, the material that they would publish, for Sponsor review and approval of this publication.
- Publication restrictions are in place
Restriction type: OTHER