Trial Outcomes & Findings for Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin (NCT NCT00958841)
NCT ID: NCT00958841
Last Updated: 2016-07-26
Results Overview
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
6 months
Results posted on
2016-07-26
Participant Flow
For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
Participant milestones
| Measure |
Pasireotide LAR 60mg
All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) \& Nelson's syndrome.
|
|---|---|
|
Overall Study
STARTED
|
118
|
|
Overall Study
Completed Month 6 (M6)
|
90
|
|
Overall Study
Entered in Extension
|
63
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
Pasireotide LAR 60mg
All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) \& Nelson's syndrome.
|
|---|---|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
|
Overall Study
Abnormal test procedure result(s)
|
3
|
|
Overall Study
Administrative problems
|
1
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
New cancer therapy
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
22
|
|
Overall Study
Completed M6/did not enter extension
|
27
|
|
Overall Study
Discontinued prior to M*
|
28
|
Baseline Characteristics
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
Baseline characteristics by cohort
| Measure |
Pasireotide LAR 60mg
n=118 Participants
All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) \& Nelson's syndrome.
|
|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 14.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
Outcome measures
| Measure |
Gastrinoma
n=13 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
n=2 Participants
One of the 10 types of PNETs analyzed.
|
Glucagonoma
n=5 Participants
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
|
46.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
Outcome measures
| Measure |
Gastrinoma
n=13 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
n=37 Participants
One of the 10 types of PNETs analyzed.
|
Glucagonoma
n=14 Participants
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
Percentage of Responders at Month 6 - Individual NETs
|
46.2 percentage of participants
|
21.6 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
Outcome measures
| Measure |
Gastrinoma
n=13 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
n=37 Participants
One of the 10 types of PNETs analyzed.
|
Glucagonoma
n=14 Participants
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
|
46.2 Percentage of participants
|
21.6 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
Outcome measures
| Measure |
Gastrinoma
n=20 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
One of the 10 types of PNETs analyzed.
|
Glucagonoma
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline
|
8 Participants
|
—
|
—
|
|
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Month 6
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
Outcome measures
| Measure |
Gastrinoma
n=39 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
One of the 10 types of PNETs analyzed.
|
Glucagonoma
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline
|
7 Participants
|
—
|
—
|
|
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Month 6
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
Outcome measures
| Measure |
Gastrinoma
n=14 Participants
One of the 10 types of PNETs analyzed
|
VIpoma
One of the 10 types of PNETs analyzed.
|
Glucagonoma
One of the 10 types of PNETs analyzed.
|
|---|---|---|---|
|
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Baseline
|
6 Participants
|
—
|
—
|
|
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Month 6
|
6 Participants
|
—
|
—
|
Adverse Events
Pancreatic NETs (PNETs)
Serious events: 10 serious events
Other events: 23 other events
Deaths: 0 deaths
Pituitary NETs (PiNETs)
Serious events: 8 serious events
Other events: 71 other events
Deaths: 0 deaths
Ectopic ACTH-secrting Tumors (EAS)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Nelsons Syndrome
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pancreatic NETs (PNETs)
n=25 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Pituitary NETs (PiNETs)
n=72 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Ectopic ACTH-secrting Tumors (EAS)
n=7 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Nelsons Syndrome
n=14 participants at risk
Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Congenital, familial and genetic disorders
Haemophilia A without inhibitors
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Diplopia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Vision blurred
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Duodenitis
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Umbilical hernia
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
General disorders
Asthenia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
General disorders
Chest pain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Drug ineffective
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
General disorders
Hypothermia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Pyrexia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Hepatobiliary disorders
Hepatic failure
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Septic shock
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
2/25
|
4.2%
3/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25
|
0.00%
0/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Hepatic encephalopathy
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Syncope
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Flushing
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Vascular disorders
Hypotension
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Thrombosis
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
Other adverse events
| Measure |
Pancreatic NETs (PNETs)
n=25 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Pituitary NETs (PiNETs)
n=72 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Ectopic ACTH-secrting Tumors (EAS)
n=7 participants at risk
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
|
Nelsons Syndrome
n=14 participants at risk
Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.0%
3/25
|
1.4%
1/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25
|
0.00%
0/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Cardiac disorders
Palpitations
|
8.0%
2/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/25
|
11.1%
8/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Cardiac disorders
Tachycardia
|
12.0%
3/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
21.4%
3/14
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Vertigo
|
16.0%
4/25
|
1.4%
1/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Blindness
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Diplopia
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Eye disorders
Dry eye
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Eye pain
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Eye disorders
Photopsia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Eye disorders
Vision blurred
|
12.0%
3/25
|
5.6%
4/72
|
0.00%
0/7
|
35.7%
5/14
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/25
|
4.2%
3/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25
|
0.00%
0/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25
|
11.1%
8/72
|
14.3%
1/7
|
28.6%
4/14
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25
|
15.3%
11/72
|
28.6%
2/7
|
35.7%
5/14
|
|
Gastrointestinal disorders
Abdominal pain lower
|
12.0%
3/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
1/25
|
12.5%
9/72
|
28.6%
2/7
|
50.0%
7/14
|
|
Gastrointestinal disorders
Anorectal discomfort
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25
|
8.3%
6/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhoea
|
44.0%
11/25
|
59.7%
43/72
|
42.9%
3/7
|
78.6%
11/14
|
|
Gastrointestinal disorders
Dry mouth
|
12.0%
3/25
|
5.6%
4/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25
|
4.2%
3/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
2/25
|
5.6%
4/72
|
0.00%
0/7
|
28.6%
4/14
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Gastrointestinal disorders
Nausea
|
44.0%
11/25
|
20.8%
15/72
|
14.3%
1/7
|
64.3%
9/14
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25
|
5.6%
4/72
|
14.3%
1/7
|
21.4%
3/14
|
|
General disorders
Asthenia
|
16.0%
4/25
|
13.9%
10/72
|
0.00%
0/7
|
14.3%
2/14
|
|
General disorders
Chest discomfort
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Chest pain
|
4.0%
1/25
|
1.4%
1/72
|
14.3%
1/7
|
7.1%
1/14
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Fatigue
|
12.0%
3/25
|
13.9%
10/72
|
14.3%
1/7
|
50.0%
7/14
|
|
General disorders
Hypothermia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Injection site erythema
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Injection site pain
|
4.0%
1/25
|
11.1%
8/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Injection site pruritus
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
General disorders
Injection site urticaria
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
General disorders
Local swelling
|
8.0%
2/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
General disorders
Malaise
|
4.0%
1/25
|
5.6%
4/72
|
0.00%
0/7
|
0.00%
0/14
|
|
General disorders
Oedema peripheral
|
20.0%
5/25
|
1.4%
1/72
|
14.3%
1/7
|
0.00%
0/14
|
|
General disorders
Pyrexia
|
8.0%
2/25
|
5.6%
4/72
|
14.3%
1/7
|
0.00%
0/14
|
|
General disorders
Thirst
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Hepatobiliary disorders
Cholelithiasis
|
12.0%
3/25
|
23.6%
17/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/25
|
12.5%
9/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Hepatobiliary disorders
Sphincter of Oddi dysfunction
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Immune system disorders
Seasonal allergy
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Infections and infestations
Bone abscess
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25
|
1.4%
1/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Infections and infestations
Cystitis
|
0.00%
0/25
|
1.4%
1/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Infections and infestations
Ear infection
|
4.0%
1/25
|
2.8%
2/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Infections and infestations
Erysipelas
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Infections and infestations
Furuncle
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Infections and infestations
Influenza
|
0.00%
0/25
|
5.6%
4/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25
|
9.7%
7/72
|
14.3%
1/7
|
21.4%
3/14
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Infections and infestations
Tooth infection
|
4.0%
1/25
|
1.4%
1/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25
|
11.1%
8/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25
|
9.7%
7/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Infections and infestations
Wound infection
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25
|
4.2%
3/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25
|
4.2%
3/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Blood corticotrophin increased
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Investigations
Blood glucagon decreased
|
0.00%
0/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Blood glucose increased
|
4.0%
1/25
|
9.7%
7/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Investigations
Blood insulin increased
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Electrocardiogram QT prolonged
|
4.0%
1/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.0%
2/25
|
6.9%
5/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Investigations
Glycosylated haemoglobin increased
|
8.0%
2/25
|
5.6%
4/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Insulin-like growth factor decreased
|
0.00%
0/25
|
5.6%
4/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Investigations
Vitamin D decreased
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Investigations
Weight decreased
|
12.0%
3/25
|
6.9%
5/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
4/25
|
6.9%
5/72
|
28.6%
2/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
16.0%
4/25
|
22.2%
16/72
|
28.6%
2/7
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25
|
5.6%
4/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
32.0%
8/25
|
36.1%
26/72
|
57.1%
4/7
|
78.6%
11/14
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/25
|
1.4%
1/72
|
28.6%
2/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.0%
2/25
|
2.8%
2/72
|
0.00%
0/7
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
2/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Polydipsia
|
8.0%
2/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
8.0%
2/25
|
2.8%
2/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25
|
8.3%
6/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
4/25
|
6.9%
5/72
|
14.3%
1/7
|
28.6%
4/14
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.0%
2/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25
|
2.8%
2/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25
|
1.4%
1/72
|
14.3%
1/7
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/25
|
5.6%
4/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25
|
11.1%
8/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Nervous system disorders
Formication
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Headache
|
20.0%
5/25
|
15.3%
11/72
|
28.6%
2/7
|
28.6%
4/14
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Nervous system disorders
Hypoaesthesia
|
8.0%
2/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Migraine
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Paraesthesia
|
12.0%
3/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Nervous system disorders
Somnolence
|
4.0%
1/25
|
1.4%
1/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Nervous system disorders
Syncope
|
4.0%
1/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
Tremor
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Nervous system disorders
VIIth nerve paralysis
|
4.0%
1/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Psychiatric disorders
Depression
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25
|
9.7%
7/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Renal and urinary disorders
Polyuria
|
8.0%
2/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary incontinence
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Menorrhagia
|
8.0%
2/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25
|
9.7%
7/72
|
14.3%
1/7
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
2/25
|
6.9%
5/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
2/25
|
0.00%
0/72
|
14.3%
1/7
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.0%
4/25
|
5.6%
4/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25
|
2.8%
2/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.0%
1/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.0%
2/25
|
4.2%
3/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.0%
4/25
|
2.8%
2/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25
|
1.4%
1/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Flushing
|
12.0%
3/25
|
0.00%
0/72
|
0.00%
0/7
|
0.00%
0/14
|
|
Vascular disorders
Hot flush
|
0.00%
0/25
|
2.8%
2/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
6.9%
5/72
|
0.00%
0/7
|
14.3%
2/14
|
|
Vascular disorders
Hypotension
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Phlebitis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
|
Vascular disorders
Poor venous access
|
0.00%
0/25
|
0.00%
0/72
|
14.3%
1/7
|
0.00%
0/14
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/25
|
0.00%
0/72
|
0.00%
0/7
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER