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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02720536
• Collaborator: (none)
• Enrollment: 53
• Locations: 14
• Arm: 1
• Actual Duration (Months): 35.2
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Condition or Disease	Intervention/Treatment	Phase
Chronic Iron Overload	Drug: Deferasirox	Phase 3

Detailed Description

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201

• Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.

• Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.

• Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201
• Actual Study Start Date: Aug 16, 2016
• Actual Primary Completion Date: Jul 23, 2019
• Actual Study Completion Date: Jul 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deferasirox Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.	Drug: Deferasirox; Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria for subjects:

• Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).

• Were deemed to have tolerated deferasirox treatment by the investigator.

• Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:

• Creatinine clearance below the contraindication limit in the locally approved prescribing information.

• Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening

• Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,

• Significant proteinuria

• Patients with significant impaired gastrointestinal function or gastrointestinal disease

• Clinical or laboratory evidence of active Hepatitis B or Hepatitis C

• Patients with psychiatric or addictive disorders

• Patients with a known history of HIV seropositivity (Elisa or Western blot).

• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

• Patients with a history of hypersensitivity to any of the study drug or excipients.

• Patients with significant medical condition that could interfere with the ability to participate in this study

• Patients who were participating in another clinical trial or receiving an investigational drug.

• Patients using prohibited medication,

• Patients with liver disease with severity of Child-Pugh Class B or C.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Vienna		Austria	1140
2	Novartis Investigative Site	Goudi-Athens	GR	Greece	115 27
3	Novartis Investigative Site	Patras		Greece	265 00
4	Novartis Investigative Site	Thessaloniki		Greece	54642
5	Novartis Investigative Site	Catania	CT	Italy	95125
6	Novartis Investigative Site	Cona	FE	Italy	44100
7	Novartis Investigative Site	Genova	GE	Italy	16128
8	Novartis Investigative Site	Cagliari	ITA	Italy	09121
9	Novartis Investigative Site	Lecce	LE	Italy	73100
10	Novartis Investigative Site	Milano	MI	Italy	20122
11	Novartis Investigative Site	Palermo	PA	Italy	90127
12	Novartis Investigative Site	Palermo	PA	Italy	90146
13	Novartis Investigative Site	Verona	VR	Italy	37126
14	Novartis Investigative Site	Napoli		Italy	80138

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Aug 26, 2019
• Study Protocol - Oct 25, 2017

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02720536
• Other Study ID Numbers: CICL670AIC04
• First Posted: Mar 28, 2016
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: adult; pediatric,; anemia.; Myelodysplastic Syndrome; Thalassemia; Film coated tablet; ICL670; MDS; Chelation; Deferasirox; Iron overload
• Additional relevant MeSH terms: Iron Overload; Deferasirox

Study Results

Participant Flow

Pre-assignment Detail	All patients completed study CICL670F2201 (NCT02125877) prior to entry into this study

Arm/Group Title	Deferasirox
Arm/Group Description	Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Period Title: Overall Study
STARTED	53
COMPLETED	34
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Deferasirox
Arm/Group Description	Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Overall Participants	53
Age, Customized (Number) [Number]
<18	3 5.7%
≥18 - <50	46 86.8%
≥ 50 - <65	1 1.9%
≥ 65	3 5.7%
Sex: Female, Male (Count of Participants)
Female	35 66%
Male	18 34%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	50 94.3%
Asian	1 1.9%
Other	2 3.8%
Main underlying disease (participants) [Number]
MDS with very low risk as per the IPSS - R	2 3.8%
MDS with low risk as per the IPSS - R	1 1.9%
MDS with INT risk as per the IPSS - R	1 1.9%
Transfusion-dependent thalassemia	49 92.5%

Outcome Measures

1. Primary Outcome

Title	Overview of Number of Participants With Adverse Events
Description	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
Time Frame	Baseline up to approximately 25 months

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Deferasirox
Arm/Group Description	Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
Measure Participants	53
Adverse events (AEs)	52 98.1%
Treatment related AEs	20 37.7%
Severe adverse events	14 26.4%
Treatment related severe adverse events	2 3.8%
Serious adverse events (SAEs)	13 24.5%
Treatment related SAEs	0 0%
Fatal SAEs	1 1.9%
Treatment related fatal SAEs	0 0%
AEs leading to discontinuation	4 7.5%
Treatment related AEs leading to discontinuation	2 3.8%
AEs leading to dose adjust/interruption	33 62.3%
AEs requiring additional therapy	4 7.5%

2. Primary Outcome

Title	Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	42	40
Baseline	3.753 (0.4909)	3.733 (0.5016)	3.746 (0.5071)
Post	NA (NA)	3.610 (0.5153)	3.607 (0.5423)
Change	NA (NA)	-0.124 (0.3892)	-0.139 (0.4330)

3. Primary Outcome

Title	Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	42	40
Baseline	9.336 (5.1383)	9.559 (5.6650)	9.100 (5.4667)
Post	NA (NA)	9.090 (4.3712)	9.007 (4.4385)
Change	NA (NA)	-0.469 (4.0727)	-0.093 (4.5792)

4. Primary Outcome

Title	Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	42	40
Baseline	330.1 (188.81)	336.5 (195.97)	339.4 (196.41)
Post	NA (NA)	344.2 (190.43)	361.9 (165.91)
Change	NA (NA)	7.7 (112.98)	22.4 (100.72)

5. Primary Outcome

Title	Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	43	40
Baseline	55.1 (16.16)	54.4 (16.34)	57.4 (16.91)
Post	NA (NA)	62.0 (16.17)	63.5 (16.78)
Change	NA (NA)	7.6 (9.51)	6.1 (11.09)

6. Primary Outcome

Title	Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	52	41	40
Baseline	131.9 (51.32)	131.8 (56.98)	129.6 (50.30)
Post	NA (NA)	116.0 (48.71)	119.8 (49.34)
Change	NA (NA)	-15.8 (35.12)	-9.8 (32.74)

7. Primary Outcome

Title	Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	44	40
Baseline	37.4 (31.47)	39.4 (33.51)	39.5 (33.32)
Post	NA (NA)	28.9 (21.12)	25.9 (19.08)
Change	NA (NA)	-10.5 (29.16)	-13.6 (27.44)

8. Primary Outcome

Title	Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Baseline of laboratory value	Change from baseline at month 6	Change from baseline at month 12
Measure Participants	53	43	39
Baseline	30.7 (24.40)	32.9 (26.48)	33.7 (26.67)
Post	NA (NA)	27.6 (18.81)	25.2 (12.78)
Change	NA (NA)	-5.3 (21.03)	-8.5 (19.18)

9. Secondary Outcome

Title	Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Serum ferritin value at baseline	Serum ferritin value at baseline and at month 6	Serum ferritin value at baseline and at month 12
Measure Participants	53	44	36
Baseline	2523.51 (1746.087)	2614.12 (1781.287)	2542.76 (1904.087)
Post	NA (NA)	2228.94 (1910.182)	1924.49 (1839.818)
Change	NA (NA)	-385.18 (1038.789)	-618.26 (1054.150)

10. Secondary Outcome

Title	Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12
Description	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
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	Month 6	Month 12
Arm/Group Description	Serum ferritin value at baseline	Serum ferritin value at baseline and at month 6	Serum ferritin value at baseline and at month 12
Measure Participants	53	44	36
Mean (Standard Deviation) [percentage of relative change]	NA (NA)	-18.61 (32.969)	-29.08 (33.056)

Adverse Events

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
Adverse Event Reporting Description	Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Arm/Group Title	Deferasirox
Arm/Group Description	Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
All Cause Mortality
	Deferasirox
	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)
Serious Adverse Events
	Deferasirox
	Affected / at Risk (%)	# Events
Total	13/53 (24.5%)
Cardiac disorders
Atrial fibrillation	1/53 (1.9%)
Cardiac failure	1/53 (1.9%)
Endocrine disorders
Goitre	1/53 (1.9%)
Hepatobiliary disorders
Biliary colic	1/53 (1.9%)
Cholecystitis	1/53 (1.9%)
Cholestasis	1/53 (1.9%)
Hepatic failure	1/53 (1.9%)
Infections and infestations
Diverticulitis	1/53 (1.9%)
Lower respiratory tract infection	1/53 (1.9%)
Lymph gland infection	1/53 (1.9%)
Urosepsis	1/53 (1.9%)
Injury, poisoning and procedural complications
Femur fracture	1/53 (1.9%)
Fracture	1/53 (1.9%)
Lumbar vertebral fracture	1/53 (1.9%)
Rib fracture	1/53 (1.9%)
Ulna fracture	1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	1/53 (1.9%)
Ovarian adenoma	1/53 (1.9%)
Papillary thyroid cancer	1/53 (1.9%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/53 (1.9%)
Product Issues
Device failure	1/53 (1.9%)
Psychiatric disorders
Panic attack	1/53 (1.9%)
Renal and urinary disorders
Calculus urinary	1/53 (1.9%)
Hydronephrosis	1/53 (1.9%)
Renal colic	1/53 (1.9%)
Ureterolithiasis	1/53 (1.9%)
Other (Not Including Serious) Adverse Events
	Deferasirox
	Affected / at Risk (%)	# Events
Total	48/53 (90.6%)
Cardiac disorders
Palpitations	3/53 (5.7%)
Gastrointestinal disorders
Abdominal pain	10/53 (18.9%)
Abdominal pain upper	11/53 (20.8%)
Constipation	3/53 (5.7%)
Diarrhoea	14/53 (26.4%)
Dyspepsia	4/53 (7.5%)
Gastritis	5/53 (9.4%)
Nausea	12/53 (22.6%)
Vomiting	12/53 (22.6%)
General disorders
Asthenia	10/53 (18.9%)
Influenza like illness	5/53 (9.4%)
Pyrexia	13/53 (24.5%)
Hepatobiliary disorders
Hypertransaminasaemia	4/53 (7.5%)
Infections and infestations
Ear infection	4/53 (7.5%)
Gastroenteritis	7/53 (13.2%)
Influenza	9/53 (17%)
Nasopharyngitis	3/53 (5.7%)
Pharyngitis	7/53 (13.2%)
Respiratory tract infection	4/53 (7.5%)
Rhinitis	8/53 (15.1%)
Sinusitis	3/53 (5.7%)
Tonsillitis	5/53 (9.4%)
Upper respiratory tract infection	4/53 (7.5%)
Urinary tract infection	6/53 (11.3%)
Investigations
Blood creatinine increased	4/53 (7.5%)
Urine protein/creatinine ratio increased	8/53 (15.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/53 (5.7%)
Back pain	5/53 (9.4%)
Musculoskeletal pain	6/53 (11.3%)
Myalgia	3/53 (5.7%)
Neck pain	3/53 (5.7%)
Pain in extremity	5/53 (9.4%)
Nervous system disorders
Headache	14/53 (26.4%)
Renal and urinary disorders
Dysuria	3/53 (5.7%)
Glycosuria	3/53 (5.7%)
Proteinuria	4/53 (7.5%)
Renal colic	3/53 (5.7%)
Respiratory, thoracic and mediastinal disorders
Cough	12/53 (22.6%)
Oropharyngeal pain	9/53 (17%)
Productive cough	3/53 (5.7%)
Vascular disorders
Hypertension	3/53 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.