Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: deferasirox every day for 77 weeks 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. |
Drug: Deferasirox
Oral deferasirox 30mg/kg/day once per day for 77 weeks.
|
Outcome Measures
Primary Outcome Measures
- Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* [From Baseline to 25, 49, 77 Week]
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).
Secondary Outcome Measures
- Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]
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).
- Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]
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.
- Serum Ferritin and Changes From Baseline in Serum Ferritin During Study [From Baseline to 25, 49, 77 Week]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as > 8 transfusions per year)
-
Lifetime minimum of 100 previous packed red blood cell transfusions
-
Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug
-
Age ≥ 10 years
-
Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.
Exclusion Criteria:
-
Ejection Fraction < 56 % measured using steady-state free precession imaging by MRI
-
Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia
-
Abnormal laboratory values as defined by the protocol
-
Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
-
History of HIV positive test result (ELISA or Western blot)
-
Uncontrolled systemic hypertension
-
Second or third degree A-V block
-
Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year
-
History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy
-
History of clinically relevant ocular toxicity related to iron chelation
-
Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
-
Pregnancy or breast feeding (documented negative pregnancy test required for study entry)
-
Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study
-
Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
-
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
-
History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
-
Other inclusion/exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Childrens Hospital of Los Angeles | Los Angeles | California | United States | 90027 |
2 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609 |
3 | Children's Memorial Hospital | Chicago | Illinois | United States | 60614 |
Sponsors and Collaborators
- Novartis
Investigators
- Principal Investigator: Thomas Coates, MD, Childresn's Hospital of Los Angeles
- Principal Investigator: Alexis Thompson, MD, Children's Memorial Hospital of Chicago
- Principal Investigator: Paul Harmatz, MD, Children's Hospital and Research Center at Oakland
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CICL670AUS04
Study Results
Participant Flow
Recruitment Details | The study was conducted at 4 centers in the United States |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 28 |
COMPLETED | 22 |
NOT COMPLETED | 6 |
Baseline Characteristics
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Overall Participants | 28 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
22.6
(8.67)
|
Sex: Female, Male (Count of Participants) | |
Female |
20
71.4%
|
Male |
8
28.6%
|
Race/Ethnicity, Customized (participants) [Number] | |
Caucasian |
9
32.1%
|
Black |
0
0%
|
Oriental |
7
25%
|
Other |
12
42.9%
|
Outcome Measures
Title | Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* |
---|---|
Description | 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). |
Time Frame | From Baseline to 25, 49, 77 Week |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed in Completer population (CP) consists of those participants who had a Week 77 MRI. |
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Measure Participants | 22 |
Baseline |
9.92
(3.922)
|
Week 25 |
11.73
(6.091)
|
Week 25 Absolute Change from Baseline |
1.77
(3.203)
|
Week 49 |
11.93
(6.489)
|
Week 49 Absolute Change from Baseline |
2.01
(3.792)
|
Week 77 |
12.10
(6.461)
|
Week 77 Absolute Change from Baseline |
2.18
(3.927)
|
Title | Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks |
---|---|
Description | 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). |
Time Frame | From Baseline to 25, 49, 77 Week |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI. |
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Measure Participants | 22 |
Baseline |
19.85
(3.309)
|
Week 25 |
17.23
(15.393)
|
Week 25 Absolute Change from Baseline |
-2.89
(4.169)
|
Week 49 |
17.0
(17.548)
|
Week 49 Absolute Change from Baseline |
-2.85
(4.883)
|
Week 77 |
16.62
(20.114)
|
Week 77 Absolute Change from Baseline |
-3.23
(7.708)
|
Title | Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks |
---|---|
Description | 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. |
Time Frame | From Baseline to 25, 49, 77 Week |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed in Completer population consisting of those participants who had a Week 77 MRI. |
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Measure Participants | 22 |
Baseline |
64.01
(6.751)
228.6%
|
Week 25 |
62.17
(6.352)
222%
|
Week 25 Absolute change from baseline |
-1.84
(7.306)
-6.6%
|
Week 49 |
61.61
(13.726)
220%
|
Week 49 Absolute change from baseline |
-2.68
(14.546)
-9.6%
|
Week 77 |
63.84
(6.112)
228%
|
Week 77 Absolute change from baseline |
0.11
(7.299)
0.4%
|
Title | Serum Ferritin and Changes From Baseline in Serum Ferritin During Study |
---|---|
Description | 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. |
Time Frame | From Baseline to 25, 49, 77 Week |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI. |
Arm/Group Title | Deferasirox |
---|---|
Arm/Group Description | 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. |
Measure Participants | 22 |
Baseline |
4343.75
(3486.525)
|
Week 25 |
4280.77
(5261.563)
|
Week 25 Absolute change from baseline |
-62.98
(2294.635)
|
Week 49 |
3759.29
(3966.107)
|
Week 49 Absolute change from baseline |
-593.36
(1534.040)
|
Week 77 |
3179.81
(3439.357)
|
Week 77 Absolute change from baseline |
-882.74
(1368.202)
|
Adverse Events
Time Frame | 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. | |
---|---|---|
Adverse Event Reporting Description | 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. | |
Arm/Group Title | All Patients | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
All Patients | ||
Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | |
Serious Adverse Events |
||
All Patients | ||
Affected / at Risk (%) | # Events | |
Total | 8/27 (29.6%) | |
Blood and lymphatic system disorders | ||
Disseminated intravascular coagulation | 1/27 (3.7%) | |
Thrombocytopenia | 1/27 (3.7%) | |
Cardiac disorders | ||
Arrhythmia | 1/27 (3.7%) | |
Cardiac failure | 1/27 (3.7%) | |
Tachycardia | 1/27 (3.7%) | |
Congenital, familial and genetic disorders | ||
Fanconi syndrome | 1/27 (3.7%) | |
Gastrointestinal disorders | ||
Abdominal compartment syndrome | 1/27 (3.7%) | |
Abdominal pain | 4/27 (14.8%) | |
Ascites | 1/27 (3.7%) | |
Colitis | 1/27 (3.7%) | |
Gastrointestinal oedema | 1/27 (3.7%) | |
Nausea | 1/27 (3.7%) | |
Pancreatitis | 1/27 (3.7%) | |
Vomiting | 3/27 (11.1%) | |
General disorders | ||
Multi-organ failure | 1/27 (3.7%) | |
Pyrexia | 5/27 (18.5%) | |
Hepatobiliary disorders | ||
Hepatic failure | 1/27 (3.7%) | |
Hepatic steatosis | 1/27 (3.7%) | |
Hepatitis | 1/27 (3.7%) | |
Infections and infestations | ||
Aspergillosis | 1/27 (3.7%) | |
Bacterial infection | 1/27 (3.7%) | |
Bronchitis viral | 1/27 (3.7%) | |
Herpes simplex | 1/27 (3.7%) | |
Pneumonia | 1/27 (3.7%) | |
Sepsis | 1/27 (3.7%) | |
Septic shock | 1/27 (3.7%) | |
Urinary tract infection | 1/27 (3.7%) | |
Urinary tract infection fungal | 1/27 (3.7%) | |
Injury, poisoning and procedural complications | ||
Fibula fracture | 1/27 (3.7%) | |
Splenic rupture | 1/27 (3.7%) | |
Tibia fracture | 1/27 (3.7%) | |
Investigations | ||
Blood creatinine increased | 1/27 (3.7%) | |
Blood phosphorus decreased | 1/27 (3.7%) | |
Ejection fraction decreased | 1/27 (3.7%) | |
Urine analysis abnormal | 1/27 (3.7%) | |
Metabolism and nutrition disorders | ||
Acidosis | 1/27 (3.7%) | |
Acidosis hyperchloraemic | 1/27 (3.7%) | |
Anorexia | 1/27 (3.7%) | |
Dehydration | 2/27 (7.4%) | |
Hyperglycaemia | 1/27 (3.7%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 1/27 (3.7%) | |
Nervous system disorders | ||
Depressed level of consciousness | 1/27 (3.7%) | |
Unresponsive to stimuli | 1/27 (3.7%) | |
Psychiatric disorders | ||
Mental status changes | 1/27 (3.7%) | |
Psychotic disorder | 1/27 (3.7%) | |
Renal and urinary disorders | ||
Azotaemia | 1/27 (3.7%) | |
Polyuria | 1/27 (3.7%) | |
Renal failure | 1/27 (3.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
Pharyngolaryngeal pain | 1/27 (3.7%) | |
Pulmonary oedema | 1/27 (3.7%) | |
Respiratory failure | 1/27 (3.7%) | |
Vascular disorders | ||
Hypoperfusion | 1/27 (3.7%) | |
Hypotension | 2/27 (7.4%) | |
Shock | 1/27 (3.7%) | |
Other (Not Including Serious) Adverse Events |
||
All Patients | ||
Affected / at Risk (%) | # Events | |
Total | 27/27 (100%) | |
Cardiac disorders | ||
Left atrial dilatation | 1/27 (3.7%) | |
Left ventricular hypertrophy | 2/27 (7.4%) | |
Sinus bradycardia | 1/27 (3.7%) | |
Sinus tachycardia | 1/27 (3.7%) | |
Tachycardia | 2/27 (7.4%) | |
Ear and labyrinth disorders | ||
Vertigo | 1/27 (3.7%) | |
Eye disorders | ||
Conjunctivitis | 1/27 (3.7%) | |
Conjunctivitis allergic | 1/27 (3.7%) | |
Dry eye | 1/27 (3.7%) | |
Eye irritation | 1/27 (3.7%) | |
Gastrointestinal disorders | ||
Abdominal pain | 7/27 (25.9%) | |
Abdominal pain lower | 1/27 (3.7%) | |
Constipation | 2/27 (7.4%) | |
Diarrhoea | 12/27 (44.4%) | |
Dyspepsia | 1/27 (3.7%) | |
Gastritis | 1/27 (3.7%) | |
Nausea | 16/27 (59.3%) | |
Vomiting | 6/27 (22.2%) | |
General disorders | ||
Chest discomfort | 3/27 (11.1%) | |
Chills | 2/27 (7.4%) | |
Fatigue | 9/27 (33.3%) | |
Non-cardiac chest pain | 1/27 (3.7%) | |
Oedema | 1/27 (3.7%) | |
Oedema peripheral | 1/27 (3.7%) | |
Pain | 2/27 (7.4%) | |
Pyrexia | 10/27 (37%) | |
Hepatobiliary disorders | ||
Cholelithiasis | 1/27 (3.7%) | |
Immune system disorders | ||
House dust allergy | 1/27 (3.7%) | |
Infections and infestations | ||
Candidiasis | 1/27 (3.7%) | |
Ear infection | 1/27 (3.7%) | |
Folliculitis | 1/27 (3.7%) | |
Fungal infection | 1/27 (3.7%) | |
Hordeolum | 1/27 (3.7%) | |
Nasopharyngitis | 11/27 (40.7%) | |
Oral herpes | 1/27 (3.7%) | |
Pharyngitis | 1/27 (3.7%) | |
Sinusitis | 3/27 (11.1%) | |
Upper respiratory tract infection | 4/27 (14.8%) | |
Urinary tract infection | 2/27 (7.4%) | |
Vulvovaginal mycotic infection | 2/27 (7.4%) | |
Injury, poisoning and procedural complications | ||
Animal bite | 1/27 (3.7%) | |
Arthropod bite | 1/27 (3.7%) | |
Arthropod sting | 1/27 (3.7%) | |
Clavicle fracture | 1/27 (3.7%) | |
Contusion | 1/27 (3.7%) | |
Excoriation | 2/27 (7.4%) | |
Joint injury | 1/27 (3.7%) | |
Thoracic vertebral fracture | 1/27 (3.7%) | |
Wrist fracture | 1/27 (3.7%) | |
Investigations | ||
Alanine aminotransferase increased | 2/27 (7.4%) | |
Aspartate aminotransferase increased | 2/27 (7.4%) | |
Blood 1,25-dihydroxycholecalciferol decreased | 1/27 (3.7%) | |
Blood creatinine increased | 2/27 (7.4%) | |
Ejection fraction decreased | 1/27 (3.7%) | |
Electrocardiogram ST-T change | 2/27 (7.4%) | |
Hepatic enzyme increased | 1/27 (3.7%) | |
Transaminases increased | 1/27 (3.7%) | |
Urine albumin/creatinine ratio abnormal | 1/27 (3.7%) | |
Urine albumin/creatinine ratio increased | 1/27 (3.7%) | |
Urine output decreased | 2/27 (7.4%) | |
Weight decreased | 1/27 (3.7%) | |
Metabolism and nutrition disorders | ||
Alkalosis | 1/27 (3.7%) | |
Anorexia | 1/27 (3.7%) | |
Carnitine deficiency | 2/27 (7.4%) | |
Copper deficiency | 1/27 (3.7%) | |
Decreased appetite | 1/27 (3.7%) | |
Dehydration | 1/27 (3.7%) | |
Hyperglycaemia | 2/27 (7.4%) | |
Hyperkalaemia | 1/27 (3.7%) | |
Hypocalcaemia | 1/27 (3.7%) | |
Hypoglycaemia | 1/27 (3.7%) | |
Hypokalaemia | 1/27 (3.7%) | |
Selenium deficiency | 1/27 (3.7%) | |
Vitamin A deficiency | 1/27 (3.7%) | |
Vitamin B complex deficiency | 3/27 (11.1%) | |
Vitamin B1 deficiency | 1/27 (3.7%) | |
Vitamin B12 deficiency | 1/27 (3.7%) | |
Vitamin B6 deficiency | 1/27 (3.7%) | |
Vitamin C deficiency | 1/27 (3.7%) | |
Vitamin D deficiency | 5/27 (18.5%) | |
Vitamin E deficiency | 1/27 (3.7%) | |
Zinc deficiency | 2/27 (7.4%) | |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 6/27 (22.2%) | |
Back pain | 3/27 (11.1%) | |
Bone pain | 1/27 (3.7%) | |
Extremity contracture | 1/27 (3.7%) | |
Flank pain | 1/27 (3.7%) | |
Joint range of motion decreased | 1/27 (3.7%) | |
Myalgia | 2/27 (7.4%) | |
Neck pain | 1/27 (3.7%) | |
Osteopenia | 1/27 (3.7%) | |
Pain in extremity | 3/27 (11.1%) | |
Nervous system disorders | ||
Basal ganglion degeneration | 1/27 (3.7%) | |
Dizziness | 5/27 (18.5%) | |
Headache | 9/27 (33.3%) | |
Hypoaesthesia | 1/27 (3.7%) | |
Paraesthesia | 1/27 (3.7%) | |
Psychiatric disorders | ||
Insomnia | 1/27 (3.7%) | |
Renal and urinary disorders | ||
Chromaturia | 1/27 (3.7%) | |
Dysuria | 1/27 (3.7%) | |
Reproductive system and breast disorders | ||
Dysmenorrhoea | 1/27 (3.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
Asthma | 1/27 (3.7%) | |
Cough | 10/27 (37%) | |
Dyspnoea | 1/27 (3.7%) | |
Nasal congestion | 4/27 (14.8%) | |
Pharyngolaryngeal pain | 3/27 (11.1%) | |
Postnasal drip | 1/27 (3.7%) | |
Respiratory tract congestion | 1/27 (3.7%) | |
Wheezing | 1/27 (3.7%) | |
Skin and subcutaneous tissue disorders | ||
Dermatitis contact | 1/27 (3.7%) | |
Ingrown hair | 1/27 (3.7%) | |
Rash | 7/27 (25.9%) | |
Skin irritation | 1/27 (3.7%) | |
Urticaria | 3/27 (11.1%) | |
Surgical and medical procedures | ||
Wisdom teeth removal | 1/27 (3.7%) | |
Vascular disorders | ||
Hypertension | 1/27 (3.7%) | |
Hypotension | 2/27 (7.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 862-778-8300 |
Novartis.email@novartis.com |
- CICL670AUS04