Trial Outcomes & Findings for An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective (NCT NCT02116803)
NCT ID: NCT02116803
Last Updated: 2018-03-01
Results Overview
Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Until the last patient discontinued dovitinib up to 30 months
Results posted on
2018-03-01
Participant Flow
Participant milestones
| Measure |
Dovitinib
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib + Fulvestrant
Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
Dovitinib
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib + Fulvestrant
Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive disease
|
4
|
0
|
|
Overall Study
Study terminated by sponsor
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective
Baseline characteristics by cohort
| Measure |
Dovitinib
n=10 Participants
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib + Fulvestrant
n=2 Participants
Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 10.55 • n=39 Participants
|
72.0 Years
STANDARD_DEVIATION 14.14 • n=41 Participants
|
62.3 Years
STANDARD_DEVIATION 11.40 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Until the last patient discontinued dovitinib up to 30 monthsPopulation: Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study.
Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.
Outcome measures
| Measure |
Dovitinib
n=10 Participants
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib + Fulvestrant
n=2 Participants
Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
|
|---|---|---|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Any Primary system organ class
|
6 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Blood and lymphatic system disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Cardiac disorders
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Ear and Labyrinth disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Endocrine disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Eye disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Gastrointestinal disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
General disorders & administration site conditions
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Infections and Infestations
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Injury, poisoning and procedural complications
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Investigations
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Metabolism and nutrition Disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Musculoskeletal and connective tissue disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Neoplasms benign, malignant & Unspecified
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Nervous system Disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Psychiatric disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Respiratory, thoracic and mediastinal disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Skin and subcutaneous tissue disorders
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Vascular disorders
|
0 Participants
|
0 Participants
|
Adverse Events
Dovitinib
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Dovitinib+Fulvestrant
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dovitinib
n=10 participants at risk
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib+Fulvestrant
n=2 participants at risk
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Cardiac disorders
BRADYCARDIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Infections and infestations
PNEUMONIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
Other adverse events
| Measure |
Dovitinib
n=10 participants at risk
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
Dovitinib+Fulvestrant
n=2 participants at risk
Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Cardiac disorders
ANGINA PECTORIS
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Eye disorders
EYE OEDEMA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
CONSTIPATION
|
30.0%
3/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
DIARRHOEA
|
30.0%
3/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
DRY MOUTH
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Gastrointestinal disorders
NAUSEA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
General disorders
ASTHENIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
General disorders
FACE OEDEMA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
General disorders
FATIGUE
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
General disorders
OEDEMA PERIPHERAL
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
General disorders
PYREXIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Infections and infestations
HERPES ZOSTER
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Infections and infestations
INFLUENZA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
BLOOD CREATININE INCREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Investigations
PLATELET COUNT DECREASED
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
50.0%
5/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
30.0%
3/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Nervous system disorders
HEADACHE
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Nervous system disorders
NEURALGIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Psychiatric disorders
RESTLESSNESS
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.0%
2/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Skin and subcutaneous tissue disorders
RASH
|
30.0%
3/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Skin and subcutaneous tissue disorders
SEBACEOUS GLAND DISORDER
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
10.0%
1/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
0.00%
0/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/10 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
50.0%
1/2 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER