Trial Outcomes & Findings for Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available. (NCT NCT02292446)

NCT ID: NCT02292446

Last Updated: 2019-07-18

Results Overview

Summary of adverse events (all grades).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

161 participants

Primary outcome timeframe

Baseline up to approximately 26 months

Results posted on

2019-07-18

Participant Flow

161 patients were included in the ruxolitinib arm and 100% of the patient's received the treatment

Participant milestones

Participant milestones
Measure	All Patients All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Overall Study STARTED	161
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Overall Study Adverse Event	12
Overall Study Death	1
Overall Study Disease progression	2
Overall Study Subject/guardian decision	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=161 Participants All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Age, Customized <= 60	52 participants n=5 Participants
Age, Customized >60	109 participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	128 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized Other	30 participants n=5 Participants
Number of participants resistant or intolerant to hydroxyurea (HU) Resistant to hydroxyurea	60 participants n=5 Participants
Number of participants resistant or intolerant to hydroxyurea (HU) Intolerant to hydroxyurea	101 participants n=5 Participants
Number of participants' frequency of phlebotomy in 52 weeks prior to screening 1 phlebotomy	21 participants n=5 Participants
Number of participants' frequency of phlebotomy in 52 weeks prior to screening 2 phlebotomies	19 participants n=5 Participants
Number of participants' frequency of phlebotomy in 52 weeks prior to screening >=3 phlebotomies	74 participants n=5 Participants
Number of participants' frequency of phlebotomy in 52 weeks prior to screening Missing	47 participants n=5 Participants
Number of participants' use of prior antineoplastic therapy Prior Hydroxyurea use	160 participants n=5 Participants
Number of participants' use of prior antineoplastic therapy Prior other anti-neoplastic medications use	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 26 months

Summary of adverse events (all grades).

Outcome measures

Outcome measures
Measure	All Patients n=161 Participants All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day	Post-baseline Post-baseline hematocrit value	Change Change from baseline
Number of Participants With Adverse Events - All Grades Serious adverse events	26 Participants	—	—
Number of Participants With Adverse Events - All Grades Adverse events	143 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: Number of participants qualifying for evaluation of change from baseline varied across visits

Change in hematocrit levels from Baseline to each visit were measured

Outcome measures

Outcome measures
Measure	All Patients n=161 Participants All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day	Post-baseline n=161 Participants Post-baseline hematocrit value	Change n=161 Participants Change from baseline
Change From Baseline in Hematocrit Levels at All Visits Week 4	45.26 percentage Standard Deviation 5.246	43.70 percentage Standard Deviation 5.220	-1.55 percentage Standard Deviation 3.652
Change From Baseline in Hematocrit Levels at All Visits Week 60	46.56 percentage Standard Deviation 5.299	40.60 percentage Standard Deviation 5.105	40.60 percentage Standard Deviation 5.929
Change From Baseline in Hematocrit Levels at All Visits Week 72	47.66 percentage Standard Deviation 5.377	40.59 percentage Standard Deviation 4.056	-7.07 percentage Standard Deviation 6.388
Change From Baseline in Hematocrit Levels at All Visits Week 8	45.21 percentage Standard Deviation 5.136	40.73 percentage Standard Deviation 4.967	-4.48 percentage Standard Deviation 5.055
Change From Baseline in Hematocrit Levels at All Visits Week 12	45.44 percentage Standard Deviation 5.324	39.97 percentage Standard Deviation 5.419	-5.47 percentage Standard Deviation 6.522
Change From Baseline in Hematocrit Levels at All Visits Week 16	45.64 percentage Standard Deviation 5.395	39.32 percentage Standard Deviation 5.454	-6.32 percentage Standard Deviation 6.928
Change From Baseline in Hematocrit Levels at All Visits Week 20	45.96 percentage Standard Deviation 5.353	40.47 percentage Standard Deviation 5.323	-5.49 percentage Standard Deviation 6.840
Change From Baseline in Hematocrit Levels at All Visits Week 24	45.93 percentage Standard Deviation 5.109	40.32 percentage Standard Deviation 4.960	-5.62 percentage Standard Deviation 6.073
Change From Baseline in Hematocrit Levels at All Visits Week 36	45.30 percentage Standard Deviation 4.602	40.43 percentage Standard Deviation 4.959	-4.86 percentage Standard Deviation 6.184
Change From Baseline in Hematocrit Levels at All Visits Week 48	45.41 percentage Standard Deviation 4.714	39.82 percentage Standard Deviation 4.959	-5.59 percentage Standard Deviation 6.318
Change From Baseline in Hematocrit Levels at All Visits Week 84	48.15 percentage Standard Deviation 5.758	41.93 percentage Standard Deviation 5.097	-6.23 percentage Standard Deviation 6.492
Change From Baseline in Hematocrit Levels at All Visits Week 96	50.03 percentage Standard Deviation 4.702	40.82 percentage Standard Deviation 4.496	-9.21 percentage Standard Deviation 6.861
Change From Baseline in Hematocrit Levels at All Visits EOT	45.38 percentage Standard Deviation 5.202	39.93 percentage Standard Deviation 5.730	-5.45 percentage Standard Deviation 5.847

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: Number of participants qualifying for evaluation of change from baseline varied across visits

Change in spleen length from Baseline to each visit

Outcome measures

Outcome measures
Measure	All Patients n=161 Participants All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day	Post-baseline n=161 Participants Post-baseline hematocrit value	Change n=161 Participants Change from baseline
Change From Baseline in Spleen Length Week 96	19.92 cm Standard Deviation 14.494	12.33 cm Standard Deviation 8.026	-7.58 cm Standard Deviation 11.237
Change From Baseline in Spleen Length End of treatment	3.03 cm Standard Deviation 3.419	0.54 cm Standard Deviation 1.661	-2.49 cm Standard Deviation 3.025
Change From Baseline in Spleen Length Week 12	23.92 cm Standard Deviation 14.618	16.83 cm Standard Deviation 12.931	-7.09 cm Standard Deviation 12.770
Change From Baseline in Spleen Length Week 24	22.66 cm Standard Deviation 14.319	16.26 cm Standard Deviation 13.896	-6.40 cm Standard Deviation 14.101
Change From Baseline in Spleen Length Week 36	21.87 cm Standard Deviation 13.228	16.70 cm Standard Deviation 14.419	-5.18 cm Standard Deviation 10.929
Change From Baseline in Spleen Length Week 48	22.14 cm Standard Deviation 13.994	18.76 cm Standard Deviation 16.880	-3.38 cm Standard Deviation 14.438
Change From Baseline in Spleen Length Week 60	20.00 cm Standard Deviation 13.007	17.35 cm Standard Deviation 12.357	-2.65 cm Standard Deviation 13.753
Change From Baseline in Spleen Length Week 72	18.41 cm Standard Deviation 13.148	13.47 cm Standard Deviation 11.441	-4.94 cm Standard Deviation 13.840
Change From Baseline in Spleen Length Week 84	19.57 cm Standard Deviation 14.233	13.36 cm Standard Deviation 9.443	-6.21 cm Standard Deviation 12.135

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: Number of participants qualifying for evaluation of change from baseline varied across visits

The MPN-SAF (Appendix 6) was a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms including: early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain, fever and weight loss. There were three recall periods used in this questionnaire, which were 24 hours for fatigue, the past week for symptoms of early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain and fever, and the past 6 months for weight loss, Each item was scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable). The MPN-SAF TSS was computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus had a possible score range of 0 to 100.

Outcome measures

Outcome measures
Measure	All Patients n=161 Participants All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day	Post-baseline n=161 Participants Post-baseline hematocrit value	Change n=161 Participants Change from baseline
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 24	22.66 scores Standard Deviation 14.319	16.26 scores Standard Deviation 13.896	-6.40 scores Standard Deviation 14.101
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 36	21.87 scores Standard Deviation 13.228	16.70 scores Standard Deviation 14.419	-5.18 scores Standard Deviation 10.929
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 48	22.14 scores Standard Deviation 13.994	18.76 scores Standard Deviation 16.880	-3.38 scores Standard Deviation 14.438
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 60	20.00 scores Standard Deviation 13.007	17.35 scores Standard Deviation 12.357	-2.65 scores Standard Deviation 13.753
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 72	18.41 scores Standard Deviation 13.148	13.47 scores Standard Deviation 11.441	-4.94 scores Standard Deviation 13.840
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) End of treatment	22.86 scores Standard Deviation 14.225	18.12 scores Standard Deviation 15.130	-4.74 scores Standard Deviation 13.954
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 12	23.92 scores Standard Deviation 14.618	16.83 scores Standard Deviation 12.931	-7.09 scores Standard Deviation 12.770
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 84	19.57 scores Standard Deviation 14.233	13.36 scores Standard Deviation 9.443	-6.21 scores Standard Deviation 12.135
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Week 96	19.92 scores Standard Deviation 14.494	12.33 scores Standard Deviation 8.026	-7.58 scores Standard Deviation 11.237

Adverse Events

All Patients

Serious events: 26 serious events

Other events: 107 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=161 participants at risk All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Blood and lymphatic system disorders Anaemia	1.2% 2/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Cardiac disorders Bundle branch block bilateral	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Cardiac disorders Pericarditis	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Cardiac disorders Ventricular extrasystoles	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Eye disorders Cataract	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Ascites	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Diarrhoea	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Retroperitoneal haematoma	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Umbilical hernia	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
General disorders Pyrexia	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Infections and infestations Appendicitis	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Infections and infestations Diverticulitis	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Infections and infestations Pneumonia	1.2% 2/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Infections and infestations Prostatitis Escherichia coli	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Injury, poisoning and procedural complications Accident	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Injury, poisoning and procedural complications Acetabulum fracture	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Injury, poisoning and procedural complications Overdose	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Injury, poisoning and procedural complications Skin injury	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Injury, poisoning and procedural complications Tendon rupture	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Musculoskeletal and connective tissue disorders Arthralgia	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.2% 2/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Nervous system disorders Dizziness	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Nervous system disorders Seizure	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Psychiatric disorders Depression	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Renal and urinary disorders Dysuria	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.62% 1/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months

Other adverse events

Other adverse events
Measure	All Patients n=161 participants at risk All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Blood and lymphatic system disorders Anaemia	21.7% 35/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Blood and lymphatic system disorders Thrombocytosis	6.8% 11/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Constipation	8.7% 14/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Gastrointestinal disorders Diarrhoea	9.3% 15/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
General disorders Asthenia	7.5% 12/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
General disorders Fatigue	8.7% 14/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Infections and infestations Nasopharyngitis	5.6% 9/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Investigations Weight increased	8.1% 13/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Nervous system disorders Dizziness	7.5% 12/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Nervous system disorders Headache	16.8% 27/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 9/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 9/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Skin and subcutaneous tissue disorders Pruritus	8.1% 13/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months
Vascular disorders Hypertension	5.6% 9/161 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 26 months

Additional Information

Study Director

Novaratis Pharmaceuticals

Phone: 888-669-6682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER