Trial Outcomes & Findings for Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF (NCT NCT01392443)
NCT ID: NCT01392443
Last Updated: 2019-09-03
Results Overview
The primary measure of spleen size was by MRI. MRIs were performed with a body coil because the objective was to measure organ volume only, not to assess for lesions. MRIs were performed by local radiologists who were instructed not to provide a quantitative measure of spleen volume, but could provide a qualitative assessment such as enlarged, smaller, larger, etc. The scans from an individual patient were to be read by a central reader upon transfer from the site radiologist.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-09-03
Participant Flow
A total of 110 patients were planned, 120 patients were enrolled and analyzed.
Participant milestones
| Measure |
Ruxolitinib
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
Ruxolitinib
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Overall Study
Disease progression
|
30
|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF
Baseline characteristics by cohort
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Age, Continuous
|
59.0 Years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Taiwanese
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.
The primary measure of spleen size was by MRI. MRIs were performed with a body coil because the objective was to measure organ volume only, not to assess for lesions. MRIs were performed by local radiologists who were instructed not to provide a quantitative measure of spleen volume, but could provide a qualitative assessment such as enlarged, smaller, larger, etc. The scans from an individual patient were to be read by a central reader upon transfer from the site radiologist.
Outcome measures
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24
|
38 Participants
|
SECONDARY outcome
Timeframe: Weeks 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, at any time pointPopulation: Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.
The best response rate was defined as the proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline at any post-baseline assessment. The best response rate was estimated with an associated 95% confidence interval.
Outcome measures
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 24
|
35.8 Percentage of participants
Interval 27.3 to 44.4
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 36
|
40.0 Percentage of participants
Interval 31.2 to 48.8
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 48
|
44.2 Percentage of participants
Interval 35.3 to 53.1
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 72
|
44.2 Percentage of participants
Interval 35.3 to 53.1
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 96
|
45.8 Percentage of participants
Interval 36.9 to 54.7
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 120
|
45.8 Percentage of participants
Interval 36.9 to 54.7
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 144
|
46.7 Percentage of participants
Interval 37.7 to 55.6
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 168
|
47.5 Percentage of participants
Interval 38.6 to 56.4
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 192
|
47.5 Percentage of participants
Interval 38.6 to 56.4
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 216
|
47.5 Percentage of participants
Interval 38.6 to 56.4
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
Week 240
|
47.5 Percentage of participants
Interval 38.6 to 56.4
|
|
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response
at any time point
|
47.5 Percentage of participants
Interval 38.6 to 56.4
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240Population: Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.
For patients who had at least one ≥ 35% reduction in spleen volume from baseline at postbaseline, the duration of response was calculated. The start date of the duration was defined as the first spleen volume measurement that was ≥ 35% reduction from baseline, and the end date of the response duration was defined as the earliest of the following: death, A ≥ 25% increase in spleen volume by MRI (or CT in applicable patients) compared to baseline, Splenic irradiation, Leukemic transformation as defined by a bone marrow or a peripheral blood blast count of ≥ 20%, Splenectomy. Duration of response is calculated only for participants who achieved at least one measured \>= 35% reduction in spleen volume at any time.
Outcome measures
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
12 weeks
|
1.00 weeks
Interval 1.0 to 1.0
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
24 weeks
|
0.96 weeks
Interval 0.86 to 0.99
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
36 weeks
|
0.96 weeks
Interval 0.86 to 0.99
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
48 weeks
|
0.93 weeks
Interval 0.82 to 0.97
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
60 weeks
|
0.93 weeks
Interval 0.82 to 0.97
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
72 weeks
|
0.91 weeks
Interval 0.79 to 0.96
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
84 weeks
|
0.89 weeks
Interval 0.77 to 0.95
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
96 weeks
|
0.89 weeks
Interval 0.77 to 0.95
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
120 weeks
|
0.89 weeks
Interval 0.77 to 0.95
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
144 weeks
|
0.85 weeks
Interval 0.71 to 0.93
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
168 weeks
|
0.79 weeks
Interval 0.62 to 0.89
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
192 weeks
|
0.75 weeks
Interval 0.57 to 0.86
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
216 weeks
|
0.75 weeks
Interval 0.57 to 0.86
|
|
Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates
240 weeks
|
NA weeks
DOR calculated with 1 measured \>= 35% reduction in spleen volume at any time - not reached for this time point.
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.
Patient reported outcomes regarding the impact of MF on patients were assessed using the EORTC QLQ-C30. Data from the EORTC QLQ-C30 questionnaire was analyzed using the standardized scores. There were 2 categories to this scale: Functional/QOL scale and Symptom and Other items scale. For each sub-scale, the raw scores were standardized in order to obtain scores ranging from 0 to 100. For Functional/QOL subscales: a higher score represents a higher/better level of functioning. For Symptoms and Other items subscales: a higher score represents worse level of symptoms. The absolute change from baseline was calculated for each scale and summarized descriptively by scheduled visit.
Outcome measures
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales: Global Health Status/QOL
|
5.2 scores on a scale
Standard Deviation 22.04
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales: Physical Functioning
|
0.6 scores on a scale
Standard Deviation 14.70
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales:Role Functioning
|
-0.2 scores on a scale
Standard Deviation 21.54
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales: Emotional Functioning
|
1.9 scores on a scale
Standard Deviation 14.14
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales: Cognitive Functioning
|
-4.0 scores on a scale
Standard Deviation 18.43
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Func./QOL scales: Social Functioning
|
0.2 scores on a scale
Standard Deviation 21.41
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Fatigue
|
-1.3 scores on a scale
Standard Deviation 20.32
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom & Other items: Nausea and Vomiting
|
0.0 scores on a scale
Standard Deviation 9.43
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Pain
|
-1.8 scores on a scale
Standard Deviation 18.99
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Dyspnea
|
2.3 scores on a scale
Standard Deviation 25.93
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Insomnia
|
-2.0 scores on a scale
Standard Deviation 30.12
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Appetite Loss
|
-6.3 scores on a scale
Standard Deviation 25.26
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Constipation
|
4.6 scores on a scale
Standard Deviation 20.02
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom and Other items: Diarrhea
|
1.7 scores on a scale
Standard Deviation 23.75
|
|
Change in EORTC QLQ-C30 Scores From Baseline in at Week 24
Symptom & Other items: Fin. difficulties
|
-2.0 scores on a scale
Standard Deviation 23.49
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.
The Seven-day modified MFSAF v2.0 is a 7-item PRO instrument based on the modified MFSAF v2.0 diary administered at specified visits. Symptoms of myelofibrosis (MF) were assessed using this instrument \& included filling up quickly/early satiety, abdominal discomfort, pain under the ribs, night sweats, itching, bone/muscle pain \& inactivity. The first 6 items assessed MF symptom severity at its worst as recalled \& the seventh captured MF-related inactivity in the 7 days prior to the clinic visit assessment. All 7 items asked subjects to record their answers on an 11-point numeric rating scale (NRS) (0=Absent, 10=Worst Imaginable). The first 6 items of the instrument focus on MF symptoms \& are summed to create a Total Symptom score, defined as the sum of the 6 individual symptom scores other than the inactivity score (each with 0-10 point scale) collected on the same week. The total symptom scale ranges from 0 -60 where higher score indicates a worse level of the condition.
Outcome measures
| Measure |
Ruxolitinib
n=120 Participants
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Change in Total Symptom Score From Baseline at Week 24 as Measured by Seven-day Modified MFSAF v2.0
|
-5.0 scores on a scale
Interval -27.0 to 21.0
|
Adverse Events
Ruxolitinib
Serious events: 60 serious events
Other events: 117 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Ruxolitinib
n=120 participants at risk
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.83%
1/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
5/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.83%
1/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.83%
1/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.83%
1/120 • 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 240 weeks.
|
|
Cardiac disorders
Cardiac failure
|
2.5%
3/120 • 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 240 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.83%
1/120 • 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 240 weeks.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.83%
1/120 • 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 240 weeks.
|
|
Cardiac disorders
Myocarditis
|
0.83%
1/120 • 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 240 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
0.83%
1/120 • 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 240 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.83%
1/120 • 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 240 weeks.
|
|
Eye disorders
Cataract
|
0.83%
1/120 • 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 240 weeks.
|
|
Eye disorders
Glaucoma
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.83%
1/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
1/120 • 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 240 weeks.
|
|
General disorders
Disuse syndrome
|
0.83%
1/120 • 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 240 weeks.
|
|
General disorders
Pyrexia
|
6.7%
8/120 • 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 240 weeks.
|
|
General disorders
Sudden death
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.83%
1/120 • 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 240 weeks.
|
|
Hepatobiliary disorders
Jaundice
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Abdominal infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Anal abscess
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Bronchitis
|
2.5%
3/120 • 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 240 weeks.
|
|
Infections and infestations
Enteritis infectious
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/120 • 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 240 weeks.
|
|
Infections and infestations
Herpes zoster
|
5.0%
6/120 • 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 240 weeks.
|
|
Infections and infestations
Infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Lung infection
|
5.0%
6/120 • 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 240 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Pneumonia
|
7.5%
9/120 • 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 240 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Post procedural infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Sepsis
|
1.7%
2/120 • 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 240 weeks.
|
|
Infections and infestations
Soft tissue infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Tuberculosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • 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 240 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.83%
1/120 • 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 240 weeks.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.83%
1/120 • 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 240 weeks.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.83%
1/120 • 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 240 weeks.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.83%
1/120 • 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 240 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.83%
1/120 • 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 240 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.83%
1/120 • 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 240 weeks.
|
|
Investigations
Bilirubin conjugated increased
|
0.83%
1/120 • 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 240 weeks.
|
|
Investigations
Blood bilirubin increased
|
1.7%
2/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.83%
1/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.83%
1/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.83%
1/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.83%
1/120 • 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 240 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.83%
1/120 • 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 240 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell crisis
|
0.83%
1/120 • 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 240 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.83%
1/120 • 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 240 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant transformation
|
0.83%
1/120 • 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 240 weeks.
|
|
Nervous system disorders
Dizziness
|
0.83%
1/120 • 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 240 weeks.
|
|
Psychiatric disorders
Depression
|
0.83%
1/120 • 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 240 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
2/120 • 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 240 weeks.
|
|
Renal and urinary disorders
Calculus bladder
|
0.83%
1/120 • 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 240 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.83%
1/120 • 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 240 weeks.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.83%
1/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.83%
1/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.83%
1/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.83%
1/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
2/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
1/120 • 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 240 weeks.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.83%
1/120 • 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 240 weeks.
|
|
Vascular disorders
Aortic dissection
|
0.83%
1/120 • 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 240 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.83%
1/120 • 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 240 weeks.
|
|
Vascular disorders
Peripheral embolism
|
0.83%
1/120 • 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 240 weeks.
|
Other adverse events
| Measure |
Ruxolitinib
n=120 participants at risk
Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
72.5%
87/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
7/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.2%
11/120 • 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 240 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.3%
34/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.8%
25/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.7%
14/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.8%
13/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Constipation
|
17.5%
21/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.0%
42/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
8/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
9/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
9.2%
11/120 • 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 240 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
9/120 • 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 240 weeks.
|
|
General disorders
Asthenia
|
15.8%
19/120 • 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 240 weeks.
|
|
General disorders
Fatigue
|
10.0%
12/120 • 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 240 weeks.
|
|
General disorders
Malaise
|
6.7%
8/120 • 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 240 weeks.
|
|
General disorders
Oedema peripheral
|
16.7%
20/120 • 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 240 weeks.
|
|
General disorders
Pain
|
9.2%
11/120 • 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 240 weeks.
|
|
General disorders
Pyrexia
|
21.7%
26/120 • 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 240 weeks.
|
|
Infections and infestations
Herpes zoster
|
15.0%
18/120 • 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 240 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
24/120 • 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 240 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
31.7%
38/120 • 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 240 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
26/120 • 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 240 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
19.2%
23/120 • 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 240 weeks.
|
|
Investigations
Blood bilirubin increased
|
7.5%
9/120 • 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 240 weeks.
|
|
Investigations
Blood creatinine increased
|
8.3%
10/120 • 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 240 weeks.
|
|
Investigations
Blood iron increased
|
5.8%
7/120 • 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 240 weeks.
|
|
Investigations
Blood urea increased
|
6.7%
8/120 • 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 240 weeks.
|
|
Investigations
C-reactive protein increased
|
9.2%
11/120 • 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 240 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
15.8%
19/120 • 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 240 weeks.
|
|
Investigations
Lymphocyte count decreased
|
9.2%
11/120 • 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 240 weeks.
|
|
Investigations
Neutrophil count decreased
|
9.2%
11/120 • 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 240 weeks.
|
|
Investigations
Platelet count decreased
|
36.7%
44/120 • 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 240 weeks.
|
|
Investigations
Weight increased
|
12.5%
15/120 • 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 240 weeks.
|
|
Investigations
White blood cell count decreased
|
6.7%
8/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
10/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.8%
7/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.2%
17/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.5%
9/120 • 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 240 weeks.
|
|
Metabolism and nutrition disorders
Iron overload
|
7.5%
9/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
10/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
10/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.2%
11/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.2%
11/120 • 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 240 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
12/120 • 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 240 weeks.
|
|
Nervous system disorders
Dizziness
|
10.8%
13/120 • 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 240 weeks.
|
|
Nervous system disorders
Headache
|
13.3%
16/120 • 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 240 weeks.
|
|
Psychiatric disorders
Insomnia
|
11.7%
14/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.8%
31/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
8/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
9/120 • 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 240 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.5%
9/120 • 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 240 weeks.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.8%
13/120 • 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 240 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
15/120 • 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 240 weeks.
|
|
Vascular disorders
Hypertension
|
10.8%
13/120 • 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 240 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER