10 and older, any sex, with Chronic Iron Overload. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overview of Number of Participants With Adverse EventsPrimary· Baseline up to approximately 25 months
Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study
Adverse events (AEs)
Group
Value
95% CI
Deferasirox
52
Treatment related AEs
Group
Value
95% CI
Deferasirox
20
Severe adverse events
Group
Value
95% CI
Deferasirox
14
Treatment related severe adverse events
Group
Value
95% CI
Deferasirox
2
Serious adverse events (SAEs)
Group
Value
95% CI
Deferasirox
13
Treatment related SAEs
Group
Value
95% CI
Deferasirox
0
Fatal SAEs
Group
Value
95% CI
Deferasirox
1
Treatment related fatal SAEs
Group
Value
95% CI
Deferasirox
0
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
3.753
± 0.4909
Month 6
3.733
± 0.5016
Month 12
3.746
± 0.5071
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
3.610
± 0.5153
Month 12
3.607
± 0.5423
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-0.124
± 0.3892
Month 12
-0.139
± 0.4330
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
9.336
± 5.1383
Month 6
9.559
± 5.6650
Month 12
9.100
± 5.4667
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
9.090
± 4.3712
Month 12
9.007
± 4.4385
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-0.469
± 4.0727
Month 12
-0.093
± 4.5792
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
330.1
± 188.81
Month 6
336.5
± 195.97
Month 12
339.4
± 196.41
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
344.2
± 190.43
Month 12
361.9
± 165.91
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
7.7
± 112.98
Month 12
22.4
± 100.72
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
55.1
± 16.16
Month 6
54.4
± 16.34
Month 12
57.4
± 16.91
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
62.0
± 16.17
Month 12
63.5
± 16.78
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
7.6
± 9.51
Month 12
6.1
± 11.09
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
131.9
± 51.32
Month 6
131.8
± 56.98
Month 12
129.6
± 50.30
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
116.0
± 48.71
Month 12
119.8
± 49.34
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-15.8
± 35.12
Month 12
-9.8
± 32.74
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
37.4
± 31.47
Month 6
39.4
± 33.51
Month 12
39.5
± 33.32
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
28.9
± 21.12
Month 12
25.9
± 19.08
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-10.5
± 29.16
Month 12
-13.6
± 27.44
Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12Primary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Baseline
Group
Value
95% CI
Baseline
30.7
± 24.40
Month 6
32.9
± 26.48
Month 12
33.7
± 26.67
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
27.6
± 18.81
Month 12
25.2
± 12.78
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-5.3
± 21.03
Month 12
-8.5
± 19.18
Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12Secondary· Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study
Baseline
Group
Value
95% CI
Baseline
2523.51
± 1746.087
Month 6
2614.12
± 1781.287
Month 12
2542.76
± 1904.087
Post
Group
Value
95% CI
Baseline
NA
± NA
Month 6
2228.94
± 1910.182
Month 12
1924.49
± 1839.818
Change
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-385.18
± 1038.789
Month 12
-618.26
± 1054.150
Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12Secondary· Baseline, 6 and 12 months
The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × (\[Post - Baseline\] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study
Group
Value
95% CI
Baseline
NA
± NA
Month 6
-18.61
± 32.969
Month 12
-29.08
± 33.056
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 25 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Deferasirox
Serious: 13/53 (25%)
Deaths: 1/53
Serious adverse events (26 terms)
Reaction
System
Deferasirox
Atrial fibrillation
Cardiac disorders
—
Cardiac failure
Cardiac disorders
—
Goitre
Endocrine disorders
—
Biliary colic
Hepatobiliary disorders
—
Cholecystitis
Hepatobiliary disorders
—
Cholestasis
Hepatobiliary disorders
—
Hepatic failure
Hepatobiliary disorders
—
Diverticulitis
Infections and infestations
—
Lower respiratory tract infection
Infections and infestations
—
Lymph gland infection
Infections and infestations
—
Urosepsis
Infections and infestations
—
Femur fracture
Injury, poisoning and procedural complications
—
Fracture
Injury, poisoning and procedural complications
—
Lumbar vertebral fracture
Injury, poisoning and procedural complications
—
Rib fracture
Injury, poisoning and procedural complications
—
Ulna fracture
Injury, poisoning and procedural complications
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 3 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02720536.