Trial Outcomes & Findings for Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment (NCT NCT00447694)

NCT ID: NCT00447694

Last Updated: 2021-06-14

Results Overview

Cardiac T2\* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2\* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: From Baseline to 25, 49, 77 Week
• Results posted on: 2021-06-14

Participant Flow

The study was conducted at 4 centers in the United States

A total number of participants planned for this study was 30. The total number of 28 participants enrolled in the study, of these 22 completed the study and 6 discontinued the study.

Participant milestones

Measure	Deferasirox Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Overall Study STARTED	28
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Deferasirox Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Overall Study Adverse Event	2
Overall Study Abnormal laboratory value	1
Overall Study Abnormal test procedure result	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Baseline characteristics by cohort

Measure	Deferasirox n=28 Participants Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Age, Continuous	22.6 years STANDARD_DEVIATION 8.67 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Oriental	7 participants n=5 Participants
Race/Ethnicity, Customized Other	12 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 25, 49, 77 Week

Population: The analysis was performed in Completer population (CP) consists of those participants who had a Week 77 MRI.

Cardiac T2* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).

Outcome measures

Measure	Deferasirox n=22 Participants Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 49 Absolute Change from Baseline	2.01 milliseconds (msec) Standard Deviation 3.792
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Baseline	9.92 milliseconds (msec) Standard Deviation 3.922
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 25	11.73 milliseconds (msec) Standard Deviation 6.091
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 25 Absolute Change from Baseline	1.77 milliseconds (msec) Standard Deviation 3.203
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 49	11.93 milliseconds (msec) Standard Deviation 6.489
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 77	12.10 milliseconds (msec) Standard Deviation 6.461
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* Week 77 Absolute Change from Baseline	2.18 milliseconds (msec) Standard Deviation 3.927

SECONDARY outcome

Timeframe: From Baseline to 25, 49, 77 Week

Population: The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.

MRI evaluation of liver iron concentration has been validated by liver biopsy (St Pierre et al 2005). Studies comparing T2* values of liver iron concentration (LIC) with LIC as assessed by biopsy have confirmed that T2* values reflect liver iron content (Wood et al 2003b). Direct tissue-validation of cardiac T2* measurements in humans has not been performed because endomyocardial biopsy is a dangerous and unreliable indicator of cardiac iron overload (Olson et al 1989, Fitchett et al 1980). However, it has been shown that cardiac T2* accurately reflects cardiac iron in a gerbil iron cardiomyopathy model (Wood et al 2004b). T2* measurements have shown excellent inter-scanner and inter-exam reproducibility, making them suitable for longitudinal monitoring (Westwood et al 2003a, Westwood et al 2003b).

Outcome measures

Measure	Deferasirox n=22 Participants Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Baseline	19.85 mg Fe/g dw liver Standard Deviation 3.309
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 25	17.23 mg Fe/g dw liver Standard Deviation 15.393
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 25 Absolute Change from Baseline	-2.89 mg Fe/g dw liver Standard Deviation 4.169
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 49	17.0 mg Fe/g dw liver Standard Deviation 17.548
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 49 Absolute Change from Baseline	-2.85 mg Fe/g dw liver Standard Deviation 4.883
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 77	16.62 mg Fe/g dw liver Standard Deviation 20.114
Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks Week 77 Absolute Change from Baseline	-3.23 mg Fe/g dw liver Standard Deviation 7.708

SECONDARY outcome

Timeframe: From Baseline to 25, 49, 77 Week

Population: The analysis was performed in Completer population consisting of those participants who had a Week 77 MRI.

Magnetic resonance imaging (MRI)-measured cardiac T2* and cardiac function reflected by left and right ventricle ejection fraction. A standardized MRI protocol for T2* acquisition technique will be used in the centers. Images will be reviewed centrally by an expert MRI reader.

Outcome measures

Measure	Deferasirox n=22 Participants Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Baseline	64.01 percentage of participants Standard Deviation 6.751
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 25	62.17 percentage of participants Standard Deviation 6.352
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 25 Absolute change from baseline	-1.84 percentage of participants Standard Deviation 7.306
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 49	61.61 percentage of participants Standard Deviation 13.726
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 49 Absolute change from baseline	-2.68 percentage of participants Standard Deviation 14.546
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 77	63.84 percentage of participants Standard Deviation 6.112
Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks Week 77 Absolute change from baseline	0.11 percentage of participants Standard Deviation 7.299

SECONDARY outcome

Timeframe: From Baseline to 25, 49, 77 Week

Population: The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.

Serum ferritin will be assessed at each study visit. Analysis was performed in Completer population consists of those participants who had a Week 77 MRI.

Outcome measures

Measure	Deferasirox n=22 Participants Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 25	4280.77 μg/L Standard Deviation 5261.563
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Baseline	4343.75 μg/L Standard Deviation 3486.525
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 25 Absolute change from baseline	-62.98 μg/L Standard Deviation 2294.635
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 49	3759.29 μg/L Standard Deviation 3966.107
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 49 Absolute change from baseline	-593.36 μg/L Standard Deviation 1534.040
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 77	3179.81 μg/L Standard Deviation 3439.357
Serum Ferritin and Changes From Baseline in Serum Ferritin During Study Week 77 Absolute change from baseline	-882.74 μg/L Standard Deviation 1368.202

Adverse Events

All Patients

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=27 participants at risk Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Blood and lymphatic system disorders Disseminated intravascular coagulation	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Arrhythmia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Cardiac failure	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Tachycardia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Congenital, familial and genetic disorders Fanconi syndrome	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Abdominal compartment syndrome	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	14.8% 4/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Ascites	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Colitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Gastrointestinal oedema	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Nausea	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Pancreatitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Vomiting	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Multi-organ failure	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Pyrexia	18.5% 5/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders Hepatic failure	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders Hepatic steatosis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders Hepatitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Aspergillosis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Bacterial infection	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Bronchitis viral	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Herpes simplex	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Pneumonia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Sepsis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Septic shock	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Urinary tract infection	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Urinary tract infection fungal	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Fibula fracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Splenic rupture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Tibia fracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Blood creatinine increased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Blood phosphorus decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Ejection fraction decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Urine analysis abnormal	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Acidosis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Acidosis hyperchloraemic	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hyperglycaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Depressed level of consciousness	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Unresponsive to stimuli	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Psychiatric disorders Mental status changes	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Psychiatric disorders Psychotic disorder	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders Azotaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders Polyuria	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders Renal failure	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Vascular disorders Hypoperfusion	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Vascular disorders Hypotension	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Vascular disorders Shock	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.

Other adverse events

Measure	All Patients n=27 participants at risk Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Cardiac disorders Left atrial dilatation	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Left ventricular hypertrophy	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Sinus bradycardia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Sinus tachycardia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Cardiac disorders Tachycardia	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Ear and labyrinth disorders Vertigo	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Eye disorders Conjunctivitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Eye disorders Conjunctivitis allergic	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Eye disorders Dry eye	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Eye disorders Eye irritation	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	25.9% 7/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain lower	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Constipation	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	44.4% 12/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Gastritis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Nausea	59.3% 16/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Vomiting	22.2% 6/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Chest discomfort	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Chills	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Fatigue	33.3% 9/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Non-cardiac chest pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Oedema	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Oedema peripheral	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Pain	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
General disorders Pyrexia	37.0% 10/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders Cholelithiasis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Immune system disorders House dust allergy	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Candidiasis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Ear infection	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Folliculitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Fungal infection	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Hordeolum	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Nasopharyngitis	40.7% 11/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Oral herpes	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Pharyngitis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Sinusitis	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Upper respiratory tract infection	14.8% 4/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Urinary tract infection	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Infections and infestations Vulvovaginal mycotic infection	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Animal bite	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Arthropod bite	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Arthropod sting	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Clavicle fracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Contusion	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Excoriation	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Joint injury	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Wrist fracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Alanine aminotransferase increased	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Aspartate aminotransferase increased	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Blood 1,25-dihydroxycholecalciferol decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Blood creatinine increased	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Ejection fraction decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Electrocardiogram ST-T change	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Hepatic enzyme increased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Transaminases increased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Urine albumin/creatinine ratio abnormal	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Urine albumin/creatinine ratio increased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Urine output decreased	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Investigations Weight decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Alkalosis	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Carnitine deficiency	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Copper deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Decreased appetite	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hyperglycaemia	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hyperkalaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hypocalcaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hypoglycaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hypokalaemia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Selenium deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin A deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin B complex deficiency	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin B1 deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin B12 deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin B6 deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin C deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin D deficiency	18.5% 5/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Vitamin E deficiency	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Zinc deficiency	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 6/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back pain	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Bone pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Extremity contracture	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Flank pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Myalgia	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Neck pain	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Osteopenia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Basal ganglion degeneration	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Dizziness	18.5% 5/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Headache	33.3% 9/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Hypoaesthesia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Nervous system disorders Paraesthesia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Psychiatric disorders Insomnia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders Chromaturia	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders Dysuria	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Reproductive system and breast disorders Dysmenorrhoea	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Asthma	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	37.0% 10/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.8% 4/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dermatitis contact	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Ingrown hair	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash	25.9% 7/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Skin irritation	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders Urticaria	11.1% 3/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Surgical and medical procedures Wisdom teeth removal	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Vascular disorders Hypertension	3.7% 1/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Vascular disorders Hypotension	7.4% 2/27 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77. The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place