Trial · NCT02720536

Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

NCT02720536, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation. Trials, record NCT02720536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720536

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
NCT number: NCT02720536
Status: Completed
Phases: Phase 3
Enrollment: 53 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Chronic Iron Overload
Interventions: Deferasirox
First posted: 2016-03-28
Last updated: 2020-03-03
Results first posted: 2020-03-03

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overview of Number of Participants With Adverse Events	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
Primary	Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12	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
Primary	Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12	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
Primary	Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12	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
Primary	Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12	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
Primary	Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12	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
Primary	Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12	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
Primary	Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12	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
Secondary	Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12	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
Secondary	Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12	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

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overview of Number of Participants With Adverse Events	Baseline up to approximately 25 months	Safety analysis set	number of participants	NUMBER
PRIMARY	Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	10^12 cells/L	MEAN
PRIMARY	Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	10^9 cells/L	MEAN
PRIMARY	Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	10^9 cells/L	MEAN
PRIMARY	Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	umol/L	MEAN
PRIMARY	Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	mL/min	MEAN
PRIMARY	Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	U/L	MEAN
PRIMARY	Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	U/L	MEAN
SECONDARY	Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	ug/l	MEAN
SECONDARY	Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12	Baseline, 6 and 12 months	Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest	percentage of relative change	MEAN

Source ClinicalTrials.gov

Results by group87

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overview of Number of Participants With Adverse Events	Deferasirox	Adverse events (AEs)	52	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Treatment related AEs	20	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Severe adverse events	14	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Treatment related severe adverse events	2	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Serious adverse events (SAEs)	13	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Treatment related SAEs	0	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Fatal SAEs	1	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Treatment related fatal SAEs	0	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	AEs leading to discontinuation	4	number of participants
Overview of Number of Participants With Adverse Events	Deferasirox	Treatment related AEs leading to discontinuation	2	number of participants

1 to 10 of 87Source ClinicalTrials.gov

See all 87 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Deferasirox	53
Overall Study	COMPLETED	Deferasirox	34
Overall Study	NOT COMPLETED	Deferasirox	19

Source ClinicalTrials.gov

Adverse events67

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Palpitations	Cardiac disorders	Deferasirox	3	53
other	Abdominal pain	Gastrointestinal disorders	Deferasirox	10	53
other	Abdominal pain upper	Gastrointestinal disorders	Deferasirox	11	53
other	Constipation	Gastrointestinal disorders	Deferasirox	3	53
other	Diarrhoea	Gastrointestinal disorders	Deferasirox	14	53
other	Dyspepsia	Gastrointestinal disorders	Deferasirox	4	53
other	Gastritis	Gastrointestinal disorders	Deferasirox	5	53
other	Nausea	Gastrointestinal disorders	Deferasirox	12	53
other	Vomiting	Gastrointestinal disorders	Deferasirox	12	53
other	Asthenia	General disorders	Deferasirox	10	53

1 to 10 of 67Source ClinicalTrials.gov

See all 67 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferasirox	1	53
Total, other adverse events	Deferasirox	48	53
Total, serious adverse events	Deferasirox	13	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32793403	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02720536

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