Trial Outcomes & Findings for Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients (NCT NCT00117507)
NCT ID: NCT00117507
Last Updated: 2021-06-24
Results Overview
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Up To Week 52
Results posted on
2021-06-24
Participant Flow
The study enrolled participants at 3 centers in United States.
A total 24 participants were enrolled in the study of which 9 participants completed the study and 15 participants discontinued from the study.
Participant milestones
| Measure |
Deferasirox
Participants received deferasirox 20mg/kg/day OD (Once Daily) per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Deferasirox
Participants received deferasirox 20mg/kg/day OD (Once Daily) per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Abnormal laboratory values
|
3
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
|
Overall Study
Patient withdrew consent
|
4
|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Baseline characteristics by cohort
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 8.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up To Week 52Population: The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse events
|
24 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Serious adverse events
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670).
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Absolute Change in Serum Ferritin From Baseline to Week 52
Baseline
|
3847.6 μg/L (microgram/litre)
Standard Deviation 2854.54
|
|
Absolute Change in Serum Ferritin From Baseline to Week 52
Week 52/EOS (end of study)
|
-729.8 μg/L (microgram/litre)
Standard Deviation 2749.35
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all patients who were registered in the study, whether or not they received treatment.
LIC was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2).
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Absolute Change in Liver Iron Concentration (LIC) From Baseline to End of Study
Baseline
|
20.64 mg iron (Fe) per gram of dry weight (dw)
Standard Deviation 9.747
|
|
Absolute Change in Liver Iron Concentration (LIC) From Baseline to End of Study
Week 52/EOS
|
-4.50 mg iron (Fe) per gram of dry weight (dw)
Standard Deviation 12.995
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
Change in transfusion requirements from baseline.
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
To Evaluate Change in Transfusion Requirements
Number of Transfusions per Patient
|
15.5 blood tranfusions
Standard Deviation 9.46
|
|
To Evaluate Change in Transfusion Requirements
Number of Units of Blood Transfused per Patient
|
34.0 blood tranfusions
Standard Deviation 24.65
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
Absolute Change in Serum Erythropoietin from baseline.
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Absolute Change in Serum Erythropoietin
Baseline
|
646.50 IU (international unit)/L (litre)
Interval 46.9 to 3779.0
|
|
Absolute Change in Serum Erythropoietin
Week 52/EOS
|
-79.00 IU (international unit)/L (litre)
Interval -949.0 to 1091.0
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
Absolute Change in Urinary Hepcidin from baseline
Outcome measures
| Measure |
Deferasirox
n=17 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Absolute Change in Urinary Hepcidin
Baseline
|
327.63 ng (nanogram)/mg (milligram) creatinine
Interval 17.5 to 1993.1
|
|
Absolute Change in Urinary Hepcidin
Week 52/EOS
|
67.32 ng (nanogram)/mg (milligram) creatinine
Interval -819.4 to 1100.1
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
Transferrin Saturation was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2)
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Absolute Change in Transferrin Saturation
Baseline
|
59.3 percentage of transferrin saturation
Standard Deviation 7.24
|
|
Absolute Change in Transferrin Saturation
Week 52/EOS (Change from baseline)
|
8.6 percentage of transferrin saturation
Standard Deviation 21.19
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) population consisted of all patients who were registered in the study, whether or not they received treatment.
LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The outcome was reported as LPI Unit, where, 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe.
Outcome measures
| Measure |
Deferasirox
n=24 Participants
Participants received deferasirox 20mg/kg/day OD per day for 12 months.
|
|---|---|
|
Labile Plasma Iron (LPI)
Baseline
|
0.70 LPI Unit
Standard Deviation 0.638
|
|
Labile Plasma Iron (LPI)
Week 52/EOS
|
0.22 LPI Unit
Standard Deviation 0.460
|
Adverse Events
Deferasirox
Serious events: 11 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Deferasirox
n=24 participants at risk
Participants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
|
|---|---|
|
Blood and lymphatic system disorders
Splenic infarction
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Arrhythmia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Ascites
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Asthenia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Chest pain
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Chills
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Concomitant disease progression
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Oedema
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Depressed level of consciousness
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
Other adverse events
| Measure |
Deferasirox
n=24 participants at risk
Participants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Monocytosis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Dilatation atrial
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Dilatation ventricular
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Palpitations
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Pericardial effusion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Ventricular tachycardia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Eye disorders
Conjunctival discolouration
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Eye disorders
Conjunctivitis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
9/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
15/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
45.8%
11/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Odynophagia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Retching
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Asthenia
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Chest pain
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Chills
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Concomitant disease progression
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Fatigue
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Feeling cold
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Malaise
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Oedema
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
25.0%
6/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Pain
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatomegaly
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Hepatobiliary disorders
Jaundice
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Catheter related infection
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Oral herpes
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Tooth infection
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Wound
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Breath sounds abnormal
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Heart rate irregular
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Lipase increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
25.0%
6/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Investigations
Weight increased
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Gout
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Migraine
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Sciatica
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Vocal cord paralysis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Restlessness
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Incontinence
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Micturition urgency
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
5/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.8%
5/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
3/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
4/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
|
Vascular disorders
Pallor
|
8.3%
2/24 • Adverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place