Trial Outcomes & Findings for Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients (NCT NCT01340651)

NCT ID: NCT01340651

Last Updated: 2014-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: Baseline to Week 16
• Results posted on: 2014-03-10

Participant Flow

Participant milestones

Measure	Ruxolitinib Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
Overall Study STARTED	41
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Ruxolitinib Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
Overall Study Adverse Event	3
Overall Study Consent Withdrawn	2
Overall Study Commercial Supply per Sponsor	12

Baseline Characteristics

Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients

Baseline characteristics by cohort

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Age, Continuous	67.2 years STANDARD_DEVIATION 7.94 • n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Safety population: All enrolled participants who took at least 1 dose of study drug.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16	78.0 Percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at > 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at > 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of > 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Overall Response (OR) at Week 16 Clinical improvement	17.1 Percentage of participants
Overall Response (OR) at Week 16 Stable disease	80.5 Percentage of participants
Overall Response (OR) at Week 16 Progressive disease	2.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.

Outcome measures

Measure	Ruxolitinib n=40 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Change From Baseline in Spleen Volume at Week 16	-22.3 Percentage change Standard Deviation 20.79

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

Spleen length was measured in centimeters by palpation.

Outcome measures

Measure	Ruxolitinib n=38 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Change From Baseline in Spleen Length at Week 16	-29.6 Percentage change Standard Deviation 34.38

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline	26.8 Percentage of participants Interval 14.2 to 42.9

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement.

Outcome measures

Measure	Ruxolitinib n=38 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Change From Baseline in the Total Symptom Score at Week 16	-50.4 Percentage change Standard Deviation 31.16

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat population: All enrolled participants.

Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16	43.9 Percentage of participants Interval 28.5 to 60.3

SECONDARY outcome

Timeframe: Day 1

Population: Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.

Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1	319 nM Standard Deviation 119

SECONDARY outcome

Timeframe: Day 1

Population: Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.

Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data.

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1	2.0 h Interval 0.5 to 8.8

SECONDARY outcome

Timeframe: Day 1

Population: Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.

Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA).

Outcome measures

Measure	Ruxolitinib n=41 Participants Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1	1550 nM*h Standard Deviation 647

Adverse Events

Ruxolitinib - Weeks 1-16

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Ruxolitinib - After Week 16

Serious events: 9 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ruxolitinib - Weeks 1-16 n=41 participants at risk Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.	Ruxolitinib - After Week 16 n=41 participants at risk At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
Blood and lymphatic system disorders Anemia	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhea	4.9% 2/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal hemorrhage	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
General disorders Generalized edema	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Clostridium difficile colitis	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Gastroenteritis	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Pneumonia	4.9% 2/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Prostate infection	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Hip fracture	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Patella fracture	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Vascular disorders Hypotension	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	2.4% 1/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.

Other adverse events

Measure	Ruxolitinib - Weeks 1-16 n=41 participants at risk Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.	Ruxolitinib - After Week 16 n=41 participants at risk At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
Gastrointestinal disorders Diarrhoea	19.5% 8/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	9.8% 4/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	7.3% 3/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
General disorders Oedema peripheral	17.1% 7/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	17.1% 7/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	9.8% 4/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	7.3% 3/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
General disorders Asthenia	7.3% 3/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	7.3% 3/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Infections and infestations Sinusitis	7.3% 3/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.
Investigations Platelet count decreased	0.00% 0/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.	14.6% 6/41 • Adverse events were collected from Baseline through the end of the study Safety population: All enrolled participants who took at least 1 dose of study drug.

Additional Information

Study Director

Incyte Corporation

Phone: 855 463-3463

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least thirty (30) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER