Trial Outcomes & Findings for Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib (NCT NCT01523171)
NCT ID: NCT01523171
Last Updated: 2026-07-16
Results Overview
Spleen volume was measured by central imaging MRI (CT scan in participants with contraindications for MRI). Analysis was performed on Per Protocol (PP) population defined as all treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume, and had no important protocol deviations that could impact on efficacy outcome. Last observation carried forward (LOCF) method was used to impute the missing data.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Baseline, End of Cycle 6
Results posted on
2026-07-16
Participant Flow
The study was conducted at 36 sites in 10 countries. A total of 97 participants were enrolled between 30 April 2012 and 02 August 2013.
All 97 enrolled participants were treated.
Participant milestones
| Measure |
Fedratinib
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
97
|
Reasons for withdrawal
| Measure |
Fedratinib
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Study terminated by sponsor
|
63
|
|
Overall Study
Allogenic stem cell transplant
|
1
|
|
Overall Study
DP-abdominal pain and progressive leucocytosis
|
1
|
|
Overall Study
Consent withdrawn by participant
|
8
|
|
Overall Study
Disease progression (DP)
|
6
|
Baseline Characteristics
Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
Baseline characteristics by cohort
| Measure |
Fedratinib
n=97 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 8.1 • n=9 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Cycle 6Population: All treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume.
Spleen volume was measured by central imaging MRI (CT scan in participants with contraindications for MRI). Analysis was performed on Per Protocol (PP) population defined as all treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume, and had no important protocol deviations that could impact on efficacy outcome. Last observation carried forward (LOCF) method was used to impute the missing data.
Outcome measures
| Measure |
Fedratinib
n=83 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Response Rate: Percentage of Participants With >=35% Reduction From Baseline in Spleen Volume at End of Cycle 6
|
55.4 percentage of participants
95% Confidence Interval 44.1 • Interval 44.1 to 66.3
|
SECONDARY outcome
Timeframe: Baseline, End of Cycle 6Population: All treated participants with baseline and at least 1 post-baseline evaluable assessment of total symptom score.
The key MF-associated symptoms were assessed using the modified Myelofibrosis Symptom Assessment Form (MFSAF) Diary: night sweats, pruritus, abdominal discomfort, early satiety, pain under ribs on left side, and bone or muscle pain. These were measured on a scale from 0 (absent) to 10 (worst imaginable). Then Total symptom score (range 0 to 60) was defined as the sum of the scores for each of the 6 symptoms of MFSAF. Higher score indicated greater severity of symptoms. Analysis was performed on MFSAF analysis population defined as all treated participants with baseline and at least 1 post-baseline evaluable assessment of total symptom score.
Outcome measures
| Measure |
Fedratinib
n=90 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Symptom Response Rate: Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score Using MFSAF at End of Cycle 6
|
25.6 percentage of participants
95% Confidence Interval 16.9 • Interval 16.9 to 35.8
|
SECONDARY outcome
Timeframe: Baseline, End of Cycle 6Population: Intent-to-treat population included all enrolled and treated participants.
Percentage of Participants with a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6.
Outcome measures
| Measure |
Fedratinib
n=97 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6
|
30.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, End of Cycle 3Population: All treated participants with a baseline and post-baseline MRI/CT scan of spleen volume at the end of cycle 3.
Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3. Analysis was performed on PP population.
Outcome measures
| Measure |
Fedratinib
n=83 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Response Rate: Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3
|
47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, End of Cycle 3, 6Population: All treated participants with a baseline and post-baseline MRI/CT scan of spleen volume at the end of cycle 3 and/or 6.
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6. Analysis was performed on PP population.
Outcome measures
| Measure |
Fedratinib
n=83 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6.
End of Cycle 3 (n=20)
|
-24.3 percent change from baseline
Interval -60.6 to 22.0
|
|
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6.
End of Cycle 6 (n=83)
|
-34.01 percent change from baseline
Interval -72.7 to 114.8
|
SECONDARY outcome
Timeframe: Pre-dose (Hour 0), 0.5, 2.5 hours post-dose on Day 1 of Cycle 1, 2, pre-dose (Hour 0) on Day 1 of Cycle 4Population: All participants who received at least 1 (even partial) cycle of study treatment and had evaluable drug concentration data.
Analysis was performed on pharmacokinetic population defined as all participants who received at least 1 (even partial) cycle of study treatment and had evaluable drug concentration data.
Outcome measures
| Measure |
Fedratinib
n=94 Participants
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Plasma Concentration of Fedratinib
Cycle 1 Predose (0 hours) (n=94)
|
1 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of Fedratinib
Cycle 1 Day 1 (0.5 to 2 hours) (n=93)
|
924.8 ng/mL
Standard Deviation 605.4
|
|
Plasma Concentration of Fedratinib
Cycle 1 Day 1 (2.5 to 4 hours) (n=93)
|
1302.8 ng/mL
Standard Deviation 708.6
|
|
Plasma Concentration of Fedratinib
Cycle 2 Day 1 Predose (0 hours) (n=85)
|
1150.1 ng/mL
Standard Deviation 652.5
|
|
Plasma Concentration of Fedratinib
Cycle 2 Day 1 (0.5 to 2 hours) (n=85)
|
1873.4 ng/mL
Standard Deviation 1081
|
|
Plasma Concentration of Fedratinib
Cycle 2 Day 1 (2.5 to 4 hours) (n=87)
|
2143 ng/mL
Standard Deviation 906.6
|
|
Plasma Concentration of Fedratinib
Cycle 4 Day 1 Predose (0 hours) (n=69)
|
1258.7 ng/mL
Standard Deviation 594.9
|
Adverse Events
Fedratinib
Serious events: 33 serious events
Other events: 95 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Fedratinib
n=97 participants at risk
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/97 • Number of events 2 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Atrial Fibrillation
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Cardiac Failure
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Myocardial Ischaemia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Sick Sinus Syndrome
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Eye disorders
Photophobia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Disease Progression
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
General Physical Health Deterioration
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Pyrexia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Hepatobiliary disorders
Cholestasis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Cellulitis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Influenza
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Lung Infection
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Pneumonia
|
4.1%
4/97 • Number of events 4 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Sepsis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Staphylococcal Sepsis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
2/97 • Number of events 2 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Platelet Count Decreased
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
2/97 • Number of events 2 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular Joint Syndrome
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
2.1%
2/97 • Number of events 2 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Nervous system disorders
Encephalopathy
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Psychiatric disorders
Panic Attack
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Nervous system disorders
Hydrocephalus
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorder
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.1%
3/97 • Number of events 3 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Vascular disorders
Shock
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Vascular disorders
Vasculitis
|
1.0%
1/97 • Number of events 1 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
Other adverse events
| Measure |
Fedratinib
n=97 participants at risk
Fedratinib in consecutive 28-day cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
48.5%
47/97 • Number of events 86 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.3%
11/97 • Number of events 18 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.8%
26/97 • Number of events 39 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.2%
7/97 • Number of events 7 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Constipation
|
20.6%
20/97 • Number of events 24 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Nausea
|
55.7%
54/97 • Number of events 74 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
5/97 • Number of events 5 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
60.8%
59/97 • Number of events 79 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
40/97 • Number of events 52 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Asthenia
|
12.4%
12/97 • Number of events 12 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Fatigue
|
15.5%
15/97 • Number of events 16 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Oedema Peripheral
|
6.2%
6/97 • Number of events 7 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Pain
|
5.2%
5/97 • Number of events 5 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
General disorders
Pyrexia
|
10.3%
10/97 • Number of events 10 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Bronchitis
|
5.2%
5/97 • Number of events 5 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Respiratory Tract Infection
|
5.2%
5/97 • Number of events 5 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.2%
6/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
6/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Infections and infestations
Urinary Tract Infection
|
12.4%
12/97 • Number of events 15 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Alanine Aminotransferase Increased
|
6.2%
6/97 • Number of events 9 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
6/97 • Number of events 8 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Blood Creatinine Increased
|
8.2%
8/97 • Number of events 10 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Lipase Increased
|
7.2%
7/97 • Number of events 10 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Investigations
Weight Decreased
|
9.3%
9/97 • Number of events 9 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.3%
9/97 • Number of events 9 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
5/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.2%
5/97 • Number of events 5 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.2%
7/97 • Number of events 7 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.2%
8/97 • Number of events 9 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
6/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.2%
6/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Nervous system disorders
Headache
|
13.4%
13/97 • Number of events 15 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Nervous system disorders
Dizziness
|
11.3%
11/97 • Number of events 14 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.4%
13/97 • Number of events 14 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.4%
12/97 • Number of events 13 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.2%
7/97 • Number of events 8 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.2%
6/97 • Number of events 7 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.5%
16/97 • Number of events 18 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
6.2%
6/97 • Number of events 6 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
|
Social circumstances
Blood Product Transfusion Dependent
|
8.2%
8/97 • Number of events 8 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
Reported adverse events and deaths are treatment emergent that is AEs that developed/worsened and death occurred during the 'on treatment period' (from the first dose of study drug to 30 days after last dose of drug).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER