Trial Outcomes & Findings for Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib (NCT NCT04884191)
NCT ID: NCT04884191
Last Updated: 2022-06-01
Results Overview
Number of patients achieving a ≥ 35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
From Baseline to Weeks 12 and 24
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
Pacritinib 100 mg QD
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
52
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI not measured for all participants
Baseline characteristics by cohort
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=52 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=161 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=52 Participants
|
11 Participants
n=55 Participants
|
16 Participants
n=54 Participants
|
43 Participants
n=161 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=52 Participants
|
44 Participants
n=55 Participants
|
38 Participants
n=54 Participants
|
118 Participants
n=161 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 8.8 • n=52 Participants
|
68.9 years
STANDARD_DEVIATION 6.9 • n=55 Participants
|
68.1 years
STANDARD_DEVIATION 8.76 • n=54 Participants
|
68.7 years
STANDARD_DEVIATION 8.14 • n=161 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=52 Participants
|
26 Participants
n=55 Participants
|
22 Participants
n=54 Participants
|
69 Participants
n=161 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=52 Participants
|
29 Participants
n=55 Participants
|
32 Participants
n=54 Participants
|
92 Participants
n=161 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=52 Participants
|
1 Participants
n=55 Participants
|
1 Participants
n=54 Participants
|
4 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=52 Participants
|
0 Participants
n=55 Participants
|
4 Participants
n=54 Participants
|
5 Participants
n=161 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=52 Participants
|
47 Participants
n=55 Participants
|
48 Participants
n=54 Participants
|
139 Participants
n=161 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=52 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=52 Participants
|
7 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
12 Participants
n=161 Participants
|
|
BMI
|
25.1 kg/m^2
STANDARD_DEVIATION 3.79 • n=44 Participants • BMI not measured for all participants
|
27.2 kg/m^2
STANDARD_DEVIATION 4.11 • n=48 Participants • BMI not measured for all participants
|
26.4 kg/m^2
STANDARD_DEVIATION 5 • n=48 Participants • BMI not measured for all participants
|
26.3 kg/m^2
STANDARD_DEVIATION 4.4 • n=140 Participants • BMI not measured for all participants
|
|
ECOG PS
0
|
11 participants
n=52 Participants
|
14 participants
n=55 Participants
|
17 participants
n=54 Participants
|
42 participants
n=161 Participants
|
|
ECOG PS
1
|
32 participants
n=52 Participants
|
29 participants
n=55 Participants
|
29 participants
n=54 Participants
|
90 participants
n=161 Participants
|
|
ECOG PS
2
|
9 participants
n=52 Participants
|
12 participants
n=55 Participants
|
8 participants
n=54 Participants
|
29 participants
n=161 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Weeks 12 and 24Number of patients achieving a ≥ 35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Spleen Volume Reduction Response (≥ 35%)
End of Week 12
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Spleen Volume Reduction Response (≥ 35%)
End of Week 24
|
0 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Weeks 12 and 24Population: The difference between the number of participants analyzed in Week 12 vs. Week 24 is the result of the number of participants that continued to complete the study. Participants that were not analyzed were withdrawn from the study for various reasons.
Percent change from baseline
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=38 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=43 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=43 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Percent Change in Spleen Volume
Week 12
|
3.19 percent change from baseline
Standard Deviation 22.613
|
6.37 percent change from baseline
Standard Deviation 31.110
|
-3.60 percent change from baseline
Standard Deviation 26.610
|
|
Percent Change in Spleen Volume
Week 24
|
-2.43 percent change from baseline
Standard Deviation 17.608
|
0.65 percent change from baseline
Standard Deviation 20.589
|
-11.30 percent change from baseline
Standard Deviation 26.417
|
PRIMARY outcome
Timeframe: From Baseline to Weeks 12 and 24Proportion of patients with ≥ 50% reduction in Total Symptom Score from baseline as assessed by the validated PRO instrument MPN-SAF TSS 2.0
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Total Symptom Score Analysis
End of Week 12
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Total Symptom Score Analysis
End of Week 24
|
2 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Weeks 12 and 24Number of patients with improvement in PGIA. The Patient Global Impression Assessment questionnaire was completed at the end of Week 12 and end of Week 24. The scores were summarized by treatment group at each visit.
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Patient Global Impression Assessment
Week 12 - Any Improved
|
17 Participants
|
21 Participants
|
23 Participants
|
|
Patient Global Impression Assessment
Week 12 -No Change
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Patient Global Impression Assessment
Week 12 -Any Worse
|
8 Participants
|
8 Participants
|
3 Participants
|
|
Patient Global Impression Assessment
Week 24 - Any Improved
|
10 Participants
|
13 Participants
|
18 Participants
|
|
Patient Global Impression Assessment
Week 24 -No Change
|
6 Participants
|
5 Participants
|
1 Participants
|
|
Patient Global Impression Assessment
Week 24 -Any Worse
|
5 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 24Rate of reduction in spleen length from baseline
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=24 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=25 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=27 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Spleen Length Reduction
|
12.42 cm
Standard Deviation 5.602
|
11.48 cm
Standard Deviation 6.501
|
11.63 cm
Standard Deviation 7.131
|
SECONDARY outcome
Timeframe: At week 24Number of patients
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=20 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=20 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=20 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Frequency of RBC's or Platelet Transfusions
|
2.27 transfusions/month
Standard Deviation 2.987
|
1.18 transfusions/month
Standard Deviation 2.553
|
2.25 transfusions/month
Standard Deviation 2.345
|
SECONDARY outcome
Timeframe: At weeks 4, 12, 24, and 30 days post End-of-Treatment visit0 = Fully active, able to carry on all pre-disease performance without restriction 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. = Dead
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 0
|
10 Participants
|
11 Participants
|
13 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 1
|
28 Participants
|
27 Participants
|
31 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 2
|
9 Participants
|
16 Participants
|
8 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 4 - 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 0
|
11 Participants
|
9 Participants
|
14 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 1
|
20 Participants
|
23 Participants
|
19 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 2
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 3
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 12 - 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 0
|
10 Participants
|
6 Participants
|
10 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 1
|
12 Participants
|
15 Participants
|
12 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 2
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Week 24 - 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 0
|
11 Participants
|
8 Participants
|
8 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 1
|
19 Participants
|
23 Participants
|
22 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 2
|
5 Participants
|
10 Participants
|
11 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 3
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
End of Treatment - 5
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Randomization through 30 days post End-of-Treatment visitPopulation: Patients with ≥ 1 TEAE
Outcome measures
| Measure |
Pacritinib 100 mg QD
n=52 Participants
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 Participants
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 Participants
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
49 Participants
|
51 Participants
|
54 Participants
|
Adverse Events
Pacritinib 100 mg QD
Serious events: 19 serious events
Other events: 24 other events
Deaths: 6 deaths
Pacritinib 100 mg BID
Serious events: 20 serious events
Other events: 34 other events
Deaths: 4 deaths
Pacritinib 200 mg BID
Serious events: 25 serious events
Other events: 36 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Pacritinib 100 mg QD
n=52 participants at risk
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 participants at risk
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 participants at risk
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Pyrexia
|
5.8%
3/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.6%
2/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.6%
3/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
General physical health deterioration
|
3.8%
2/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Disease progression
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Drug withdrawal syndrome
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Oedema peripheral
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Asthenia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.6%
2/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Pneumonia
|
3.8%
2/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.6%
2/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
9.3%
5/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Cellulitis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Post procedural infection
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Pyelonephritis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Tuberculosis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.6%
2/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Abscess limb
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Herpes oesophagitis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Injury, poisoning and procedural complications
Delayed haemolytic transfusion reaction
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Injury, poisoning and procedural complications
Incorrect drug administration duration
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Investigations
Troponin increased
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Nervous system disorders
Optic neuritis
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Nervous system disorders
Headache
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
2/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Lung infiltration
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Vascular disorders
Haematoma
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Vascular disorders
Vascular compression
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Vascular disorders
Hypotension
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
Other adverse events
| Measure |
Pacritinib 100 mg QD
n=52 participants at risk
Pacritinib: Pacritinib
|
Pacritinib 100 mg BID
n=55 participants at risk
Pacritinib: Pacritinib
|
Pacritinib 200 mg BID
n=54 participants at risk
Pacritinib: Pacritinib
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
6/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
14.5%
8/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
25.9%
14/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Gastrointestinal disorders
Nausea
|
13.5%
7/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
12.7%
7/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.6%
3/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.8%
3/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
9.1%
5/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
16.7%
9/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Fatigue
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
12.7%
7/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
9.3%
5/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
11.1%
6/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
3/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.6%
2/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.6%
3/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Investigations
Ejection fraction decreased
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
3.7%
2/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
2/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.6%
3/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Infections and infestations
Bronchitis
|
5.8%
3/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.8%
1/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
General disorders
Pyrexia
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
1.9%
1/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
5.5%
3/55 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
0.00%
0/54 • The end of assigned study drug + 30 days
AEs analyzed in the Safety Population
|
Additional Information
John Volpone SVP, Strategic Operations
CTI BioPharma, Inc.
Phone: +1 (206) 272-4652
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place