Trial Outcomes & Findings for RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe (NCT NCT00688623)
NCT ID: NCT00688623
Last Updated: 2019-01-25
Results Overview
Overall response rate (ORR) was based on RECIST central assessment and defined as the percentage of patients with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR). The BOR was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments obtained within 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. CR required disappearance of all target and non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
baseline up to approximately 12 months
Results posted on
2019-01-25
Participant Flow
Eighty-two patients were screened and 73 were treated with study drug.
Participant milestones
| Measure |
Everolimus
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
Safety Analysis Set
|
73
|
|
Overall Study
Per Protocol (PP)
|
60
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Everolimus
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
abnormal lab value
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
3
|
|
Overall Study
disease progression
|
23
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
Baseline characteristics by cohort
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Tumor histology/cytology
Bronchial (thymic) carcinoid -typical
|
9 Participants
n=5 Participants
|
|
Tumor histology/cytology
Bronchial (thymic) carcinoid -atypical
|
12 Participants
n=5 Participants
|
|
Tumor histology/cytology
Neuroendocrine tumor
|
16 Participants
n=5 Participants
|
|
Tumor histology/cytology
Neuroendocrine carcinoma
|
36 Participants
n=5 Participants
|
|
Time since first diagnosis
< 1 year
|
19 Participants
n=5 Participants
|
|
Time since first diagnosis
1 year to < 3 years
|
26 Participants
n=5 Participants
|
|
Time since first diagnosis
3 years to < 6 years
|
17 Participants
n=5 Participants
|
|
Time since first diagnosis
6 years to < 10 years
|
3 Participants
n=5 Participants
|
|
Time since first diagnosis
≥ 10 years
|
6 Participants
n=5 Participants
|
|
Time since first diagnosis
Missing
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline up to approximately 12 monthsOverall response rate (ORR) was based on RECIST central assessment and defined as the percentage of patients with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR). The BOR was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments obtained within 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. CR required disappearance of all target and non-target lesions.
Outcome measures
| Measure |
Everolimus
n=60 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Complete response (CR)
|
0.0 percentage of participants
|
|
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Partial response
|
0.0 percentage of participants
|
|
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Stable disease (SD)
|
56.7 percentage of participants
|
|
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Progressive disease (PD)
|
43.3 percentage of participants
|
|
Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)
Unknown
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: baseline up to approximately 12 monthsOverall Response Rate (ORR) was calculated for total PP population based on central review as confirmatory, primary analysis as well as for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CI) computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected. The primary analysis was based on the PP Set
Outcome measures
| Measure |
Everolimus
n=60 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Percentage of Participants With Objective Response Rate at 12 Months - Per Protocol Set (PP)
|
0.0 percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: baseline up to approximately 12 monthsThe best overall response (BOR) was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed not less than 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. CR required disappearance of all target and non-target lesions.
Outcome measures
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Complete response (CR)
|
0.0 percentage of participants
|
|
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Partial response
|
0.0 percentage of participants
|
|
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Stable disease (SD)
|
74.0 percentage of participants
|
|
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Progressive disease (PD)
|
16.4 percentage of participants
|
|
Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set
Unknown
|
9.6 percentage of participants
|
PRIMARY outcome
Timeframe: baseline up to approximately 12 monthsOverall Response Rate (ORR) was presented for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CL; computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected.
Outcome measures
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Percentage of Participants With Objective Response Rate at 12 Months ITT Set
|
0.0 percentage of participants
Interval 0.0 to 3.1
|
SECONDARY outcome
Timeframe: baseline up to approximately 12 monthsPopulation: subjects who met required criteria
DCR was based on central radiologic review and is defined as the percentage of patients with a best overall response of 'Complete response' (CR), 'Partial response' (PR) or 'Stable disease' (SD). Relative frequencies together with their exact 2-sided 80% confidence intervals were presented
Outcome measures
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Percentage of Participants With Disease Control Rate (DCR) at 12 Months for Per Protocol (PP) and ITT Sets
DCR for Per protocol set
|
56.7 percentage of participants
Interval 47.6 to 65.4
|
|
Percentage of Participants With Disease Control Rate (DCR) at 12 Months for Per Protocol (PP) and ITT Sets
DCR for Intent to treat set
|
50.7 percentage of participants
Interval 42.6 to 58.8
|
SECONDARY outcome
Timeframe: baseline up to approximately 12 monthsPopulation: The resulting values showed a high variation and were not interpretable, as different methodology was used for the assessment of CgA at the individual centers.
Biochemical response was defined as level and change from baseline in CgA during the course of the trial. The resulting values showed a high variation and were not interpretable, as different methodology was used for the assessment of CgA at the individual centers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline up to approximately 12 monthsPopulation: subjects who met required criteria
Duration of PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause. Observations from patients not experiencing tumor progression or death at date of database closure were censored with the date of their last adequate tumor assessment. Progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Duration of Progression Free Survival (PFS) for Per Protocol (PP) and ITT Sets
PFS days for Per protocol set
|
185 days
Interval 160.0 to 262.0
|
|
Duration of Progression Free Survival (PFS) for Per Protocol (PP) and ITT Sets
PFS days for Intent to treat set
|
190 days
Interval 161.0 to 262.0
|
SECONDARY outcome
Timeframe: baseline up to approximately 15 monthsPopulation: subjects who met required criteria
OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died at date of database closure, overall survival was censored at the date of last contact.
Outcome measures
| Measure |
Everolimus
n=73 Participants
10 mg/day dose of everolimus was given by continuous oral daily dosing of two 5 mg tablets
|
|---|---|
|
Overall Survival (OS) for Per Protocol (PP) and ITT Sets
OS for Per protocol set
|
451.8 days
Standard Error 19.8
|
|
Overall Survival (OS) for Per Protocol (PP) and ITT Sets
OS for Intent to treat set
|
437.1 days
Standard Error 18.6
|
Adverse Events
Everolimus
Serious events: 48 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus
n=73 participants at risk
Everolimus
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Blood and lymphatic system disorders
Lymphatic obstruction
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Arrhythmia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Atrioventricular block
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Palpitations
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Eye disorders
Retinal detachment
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Ascites
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.1%
3/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Subileus
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Asthenia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Fatigue
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
General physical health deterioration
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Oedema
|
4.1%
3/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Oedema peripheral
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Pyrexia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Sudden death
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Hepatobiliary disorders
Cholangitis
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Febrile infection
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Gastrointestinal infection
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
H1N1 influenza
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Liver abscess
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Lung abscess
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Lymphangitis
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Pneumonia
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Pseudomonas infection
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Pyelonephritis acute
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Subdiaphragmatic abscess
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Injury, poisoning and procedural complications
Expired product administered
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
3/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Aspartate aminotransferase increased
|
4.1%
3/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood potassium decreased
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Haemoglobin decreased
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
3/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Nervous system disorders
Presyncope
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Psychiatric disorders
Completed suicide
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Psychiatric disorders
Restlessness
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Renal and urinary disorders
Incontinence
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Surgical and medical procedures
Astringent therapy
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Aortic rupture
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Circulatory collapse
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Lymphoedema
|
1.4%
1/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
Other adverse events
| Measure |
Everolimus
n=73 participants at risk
Everolimus
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
11/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Cardiac disorders
Tachycardia
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Abdominal pain
|
24.7%
18/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.3%
9/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Constipation
|
12.3%
9/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
41.1%
30/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.4%
12/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Nausea
|
30.1%
22/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Stomatitis
|
20.5%
15/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Gastrointestinal disorders
Vomiting
|
24.7%
18/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Asthenia
|
26.0%
19/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Chest pain
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Chills
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Fatigue
|
26.0%
19/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Mucosal inflammation
|
24.7%
18/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Oedema
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Oedema peripheral
|
20.5%
15/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Pain
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
General disorders
Pyrexia
|
15.1%
11/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Conjunctivitis
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Cystitis
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Pneumonia
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Respiratory tract infection
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Infections and infestations
Urinary tract infection
|
15.1%
11/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood alkaline phosphatase increased
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood glucose increased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood potassium decreased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Blood triglycerides increased
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Haemoglobin decreased
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Neutrophil count decreased
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Platelet count decreased
|
8.2%
6/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
Weight decreased
|
23.3%
17/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Investigations
White blood cell count decreased
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.5%
23/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
16.4%
12/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.2%
6/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.3%
9/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
12/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Nervous system disorders
Dizziness
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Nervous system disorders
Dysgeusia
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Nervous system disorders
Headache
|
13.7%
10/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Nervous system disorders
Lethargy
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Psychiatric disorders
Depression
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Psychiatric disorders
Insomnia
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.5%
23/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.7%
18/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.7%
10/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
9.6%
7/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.0%
8/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
43.8%
32/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Flushing
|
5.5%
4/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
|
Vascular disorders
Hypertension
|
6.8%
5/73 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 15 months
|
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 the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER