Trial Outcomes & Findings for Pacritinib Versus Best Available Therapy to Treat Myelofibrosis (NCT NCT01773187)
NCT ID: NCT01773187
Last Updated: 2020-09-29
Results Overview
Number of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-09-29
Participant Flow
Participant milestones
| Measure |
Pacritinib
Pacritinib 400 mg QD
|
Best Available Therapy
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
|---|---|---|
|
Overall Study
STARTED
|
220
|
107
|
|
Overall Study
COMPLETED
|
167
|
75
|
|
Overall Study
NOT COMPLETED
|
53
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis
Baseline characteristics by cohort
| Measure |
Pacritinib
n=220 Participants
Pacritinib 400 mg QD
|
Best Available Therapy
n=107 Participants
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
135 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
16 participants
n=5 Participants
|
4 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
49 participants
n=5 Participants
|
21 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=5 Participants
|
6 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
29 participants
n=5 Participants
|
17 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
France
|
26 participants
n=5 Participants
|
9 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
35 participants
n=5 Participants
|
18 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Number of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT)
Outcome measures
| Measure |
Pacritinib
n=220 Participants
Pacritinib 400 mg QD
|
Best Available Therapy
n=107 Participants
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
|---|---|---|
|
Spleen Volume Reduction
|
42 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The original version (MPN-SAF TSS) was administered to the first 179 subjects enrolled in the study. The subsequent 148 enrolled subjects were administered the MPN-SAF TSS 2.0 and comprise the ITT population for this endpoint.
Number of patients with \>= 50% reduction in total score from baseline to week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0). Responses (on a scale from 0 \[absent\] to 10 \[worst imaginable\]) to questions about symptoms (tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under the ribs on the left side) were used to calculate the TSS.
Outcome measures
| Measure |
Pacritinib
n=100 Participants
Pacritinib 400 mg QD
|
Best Available Therapy
n=48 Participants
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
|---|---|---|
|
Total Symptom Score (TSS) Reduction
|
19 Participants
|
5 Participants
|
Adverse Events
Pacritinib
Serious events: 117 serious events
Other events: 207 other events
Deaths: 27 deaths
Best Available Therapy
Serious events: 33 serious events
Other events: 81 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pacritinib
n=220 participants at risk
Pacritinib 400 mg QD
|
Best Available Therapy
n=106 participants at risk
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell Carcinoma
|
2.7%
6/220 • Number of events 6 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
1.9%
2/106 • Number of events 2 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squarmous cell Carcinoma
|
1.8%
4/220 • Number of events 10 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.94%
1/106 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.4%
3/220 • Number of events 7 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.94%
1/106 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.8%
4/220 • Number of events 6 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.94%
1/106 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.94%
1/106 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
5/220 • Number of events 5 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.91%
2/220 • Number of events 2 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
3.8%
4/106 • Number of events 5 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Blood and lymphatic system disorders
Anemia
|
7.3%
16/220 • Number of events 20 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
4.7%
5/106 • Number of events 106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
4/220 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.4%
3/220 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Disease Progression
|
2.7%
6/220 • Number of events 6 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
2.8%
3/106 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Pyrexia
|
2.7%
6/220 • Number of events 6 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
2.8%
3/106 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Multi-organ failure
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
4/220 • Number of events 5 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
1.9%
2/106 • Number of events 2 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.8%
4/220 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Pneumonia
|
7.3%
16/220 • Number of events 21 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
3.8%
4/106 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Lobar pneumonia
|
1.8%
4/220 • Number of events 4 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.4%
3/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.94%
1/106 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Sepis
|
0.91%
2/220 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
1.9%
2/106 • Number of events 2 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Cardiac disorders
Cardiac Failure
|
3.2%
7/220 • Number of events 7 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
2.8%
3/106 • Number of events 3 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clonal evolution
|
0.45%
1/220 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.45%
1/220 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoma
|
0.45%
1/220 • Number of events 1 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
Other adverse events
| Measure |
Pacritinib
n=220 participants at risk
Pacritinib 400 mg QD
|
Best Available Therapy
n=106 participants at risk
BAT includes any physician-selected treatment for primary or secondary myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
12/220 • Number of events 12 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
20/220 • Number of events 20 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
8.5%
9/106 • Number of events 9 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Vascular disorders
Hypertension
|
5.0%
11/220 • Number of events 11 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Fatigue
|
15.0%
33/220 • Number of events 33 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
8.5%
9/106 • Number of events 9 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Oedema peripheral
|
10.9%
24/220 • Number of events 24 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
15.1%
16/106 • Number of events 16 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Pyrexia
|
7.7%
17/220 • Number of events 17 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
10.4%
11/106 • Number of events 11 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
General disorders
Asthernia
|
7.3%
16/220 • Number of events 16 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
6.6%
7/106 • Number of events 7 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Psychiatric disorders
Insomnia
|
5.9%
13/220 • Number of events 13 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
11/220 • Number of events 11 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.5%
12/220 • Number of events 12 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.4%
58/220 • Number of events 58 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
17.0%
18/106 • Number of events 18 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.8%
48/220 • Number of events 48 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
14.2%
15/106 • Number of events 15 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
17/220 • Number of events 17 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
9.4%
10/106 • Number of events 10 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
18/220 • Number of events 18 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
7.5%
8/106 • Number of events 8 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal
|
5.9%
13/220 • Number of events 13 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Nervous system disorders
Headache
|
5.5%
12/220 • Number of events 12 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Diarrhoea
|
64.5%
142/220 • Number of events 142 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
13.2%
14/106 • Number of events 14 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Nausea
|
31.8%
70/220 • Number of events 70 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
6.6%
7/106 • Number of events 7 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
46/220 • Number of events 46 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
6.6%
7/106 • Number of events 7 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.2%
29/220 • Number of events 29 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
10.4%
11/106 • Number of events 11 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
22/220 • Number of events 22 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
7.5%
8/106 • Number of events 8 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
14/220 • Number of events 14 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Skin and subcutaneous tissue disorders
Rush
|
5.5%
12/220 • Number of events 12 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Skin and subcutaneous tissue disorders
Arthralgia
|
5.9%
13/220 • Number of events 13 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Skin and subcutaneous tissue disorders
Pain in extremity
|
5.0%
11/220 • Number of events 11 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
8.5%
9/106 • Number of events 9 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
21/220 • Number of events 21 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
16/220 • Number of events 16 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
5.7%
6/106 • Number of events 6 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
12/220 • Number of events 12 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
0.00%
0/106 • Time of signing informed consent through 30 days after the last study treatment.
The data display threshold for SAEs is set to 1% or more, that of AEs is set to 5% or more.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER