Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01033747
Collaborator
(none)
70
4
2
59
17.5
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
70 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20 mg/kg/Day of Deferasirox in Comparison With 40 mg/kg/Day Deferoxamine in Patients With Transfusion-dependent Iron Overload
Study Start Date
:
Feb 1, 2003
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Jan 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deferasirox Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study |
Drug: Deferasirox
10 mg/kg or 30 mg/kg orally daily
|
| Experimental: Deferasirox Crossover Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5mg/kg/day to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study |
Drug: Deferasirox
5 mg/kg or 30 mg/kg orally daily
|
Outcome Measures
Primary Outcome Measures
- The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox [Baseline to 7 Years]
The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.
Secondary Outcome Measures
- Relative Change in Serum Ferritin From Baseline to 3.5 Years [Baseline to 3.5 years]
The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
-
Patients currently participating in the food-effect sub-study, according to amendment
-
Ability to provide written informed consent prior to participation in this non-comparative extension study.
-
Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
-
Body weight of at least 35 kg.
Exclusion Criteria:
-
Pregnant or breastfeeding patients.
-
History of non-compliance to medical regimens and patients who are considered potentially unreliable.
-
Proteinuria > 300 mg/L second void morning urine.
-
Patients with serum creatinine above the upper limit normal.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Cagliari | Italy | ||
| 2 | Novartis Investigative Site | Genova | Italy | ||
| 3 | Novartis Investigative Site | Milan | Italy | ||
| 4 | Novartis Investigative Site | Torino | Italy |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01033747
Other Study ID Numbers:
- CICL670A0105E2
First Posted:
Dec 16, 2009
Last Update Posted:
Aug 11, 2011
Last Verified:
Jul 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This 5 year extension study includes participants treated in one or more studies: a 1 year main study to evaluate the safety,tolerability and the effects of 2 doses of deferasirox on liver iron content in comparison to standard chelation therapy with DFO, a 3 week food effect sub-study and a 12-21 month prolongation phase(NCT00379483). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Deferasirox | Deferasirox Crossover |
|---|---|---|
| Arm/Group Description | Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study | Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study |
| Period Title: Overall Study | ||
| STARTED | 51 | 19 |
| COMPLETED | 14 | 4 |
| NOT COMPLETED | 37 | 15 |
Baseline Characteristics
| Arm/Group Title | Deferasirox | Deferasirox Crossover | Total |
|---|---|---|---|
| Arm/Group Description | Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study | Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study | Total of all reporting groups |
| Overall Participants | 51 | 19 | 70 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
24.7
(5.43)
|
23.8
(3.76)
|
24.5
(5.02)
|
| Age, Customized (participants) [Number] | |||
| 16 to 49 |
50
98%
|
19
100%
|
69
98.6%
|
| 50 to 65 years |
1
2%
|
0
0%
|
1
1.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
35
68.6%
|
10
52.6%
|
45
64.3%
|
| Male |
16
31.4%
|
9
47.4%
|
25
35.7%
|
| Region of Enrollment (participants) [Number] | |||
| Italy |
51
100%
|
19
100%
|
70
100%
|
Outcome Measures
| Title | The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox |
|---|---|
| Description | The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100. |
| Time Frame | Baseline to 7 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the full analysis set treated with deferasirox for more than 3.5 years. |
| Arm/Group Title | Deferasirox | Deferasirox Crossover |
|---|---|---|
| Arm/Group Description | Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study | Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study |
| Measure Participants | 36 | 8 |
| Mean (Full Range) [Percent change] |
-21.9
(47.11)
|
-23.1
(33.38)
|
| Title | Relative Change in Serum Ferritin From Baseline to 3.5 Years |
|---|---|
| Description | The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100. |
| Time Frame | Baseline to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants comprised of the full analysis set were evaluated for the change in serum ferritin. |
| Arm/Group Title | Deferasirox | Deferasirox Crossover |
|---|---|---|
| Arm/Group Description | Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study | Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study |
| Measure Participants | 51 | 19 |
| Mean (Full Range) [Percent change] |
32.4
|
33.2
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Deferasirox | Deferasirox Crossover | ||
| Arm/Group Description | Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study | Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study. | ||
All Cause Mortality |
||||
| Deferasirox | Deferasirox Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Deferasirox | Deferasirox Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/51 (35.3%) | 2/19 (10.5%) | ||
| Blood and lymphatic system disorders | ||||
| Extramedullary haemopoiesis | 1/51 (2%) | 0/19 (0%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 1/51 (2%) | 0/19 (0%) | ||
| Atrial fibrillation | 1/51 (2%) | 0/19 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/51 (3.9%) | 0/19 (0%) | ||
| General disorders | ||||
| Chest pain | 1/51 (2%) | 0/19 (0%) | ||
| Oedema peripheral | 1/51 (2%) | 0/19 (0%) | ||
| Pyrexia | 1/51 (2%) | 0/19 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 1/51 (2%) | 0/19 (0%) | ||
| Infections and infestations | ||||
| Bacterial infection | 1/51 (2%) | 0/19 (0%) | ||
| Bronchitis | 1/51 (2%) | 0/19 (0%) | ||
| Bronchopneumonia | 1/51 (2%) | 0/19 (0%) | ||
| Gastroenteritis | 0/51 (0%) | 1/19 (5.3%) | ||
| Nasal abscess | 1/51 (2%) | 0/19 (0%) | ||
| Pyelonephritis | 1/51 (2%) | 0/19 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Femur fracture | 1/51 (2%) | 0/19 (0%) | ||
| Head injury | 1/51 (2%) | 0/19 (0%) | ||
| Injury | 1/51 (2%) | 0/19 (0%) | ||
| Neck injury | 1/51 (2%) | 0/19 (0%) | ||
| Radius fracture | 1/51 (2%) | 0/19 (0%) | ||
| Tendon injury | 0/51 (0%) | 1/19 (5.3%) | ||
| Investigations | ||||
| Electrocardiogram QT prolonged | 1/51 (2%) | 0/19 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 1/51 (2%) | 0/19 (0%) | ||
| Metabolic acidosis | 1/51 (2%) | 0/19 (0%) | ||
| Metabolic disorder | 1/51 (2%) | 0/19 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/51 (3.9%) | 0/19 (0%) | ||
| Back pain | 1/51 (2%) | 0/19 (0%) | ||
| Bone pain | 1/51 (2%) | 0/19 (0%) | ||
| Tendon disorder | 1/51 (2%) | 0/19 (0%) | ||
| Nervous system disorders | ||||
| Headache | 0/51 (0%) | 1/19 (5.3%) | ||
| Monoparesis | 1/51 (2%) | 0/19 (0%) | ||
| Paraesthesia | 0/51 (0%) | 1/19 (5.3%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 1/51 (2%) | 0/19 (0%) | ||
| Renal and urinary disorders | ||||
| Renal colic | 3/51 (5.9%) | 0/19 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/51 (2%) | 0/19 (0%) | ||
| Nasal septum deviation | 1/51 (2%) | 0/19 (0%) | ||
| Nasal turbinate hypertrophy | 1/51 (2%) | 0/19 (0%) | ||
| Surgical and medical procedures | ||||
| Cholecystectomy | 1/51 (2%) | 0/19 (0%) | ||
| Splenectomy | 1/51 (2%) | 0/19 (0%) | ||
| Surgery | 1/51 (2%) | 0/19 (0%) | ||
| Vascular disorders | ||||
| Thrombophlebitis | 2/51 (3.9%) | 0/19 (0%) | ||
| Venous thrombosis | 1/51 (2%) | 0/19 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Deferasirox | Deferasirox Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/51 (98%) | 19/19 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 3/51 (5.9%) | 0/19 (0%) | ||
| Cardiac disorders | ||||
| Cardiac failure | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Palpitations | 7/51 (13.7%) | 1/19 (5.3%) | ||
| Tachycardia | 6/51 (11.8%) | 5/19 (26.3%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 5/51 (9.8%) | 2/19 (10.5%) | ||
| Vertigo | 9/51 (17.6%) | 4/19 (21.1%) | ||
| Endocrine disorders | ||||
| Hypogonadism | 5/51 (9.8%) | 0/19 (0%) | ||
| Eye disorders | ||||
| Chalazion | 3/51 (5.9%) | 0/19 (0%) | ||
| Conjunctivitis | 3/51 (5.9%) | 0/19 (0%) | ||
| Conjunctivitis allergic | 5/51 (9.8%) | 2/19 (10.5%) | ||
| Eyelid oedema | 0/51 (0%) | 1/19 (5.3%) | ||
| Scotoma | 0/51 (0%) | 1/19 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/51 (2%) | 3/19 (15.8%) | ||
| Abdominal pain | 24/51 (47.1%) | 5/19 (26.3%) | ||
| Abdominal pain upper | 22/51 (43.1%) | 6/19 (31.6%) | ||
| Aphthous stomatitis | 0/51 (0%) | 1/19 (5.3%) | ||
| Colitis | 1/51 (2%) | 1/19 (5.3%) | ||
| Constipation | 3/51 (5.9%) | 4/19 (21.1%) | ||
| Diarrhoea | 20/51 (39.2%) | 8/19 (42.1%) | ||
| Dyspepsia | 9/51 (17.6%) | 2/19 (10.5%) | ||
| Enteritis | 8/51 (15.7%) | 3/19 (15.8%) | ||
| Gastritis | 6/51 (11.8%) | 2/19 (10.5%) | ||
| Nausea | 19/51 (37.3%) | 4/19 (21.1%) | ||
| Rectal prolapse | 0/51 (0%) | 1/19 (5.3%) | ||
| Toothache | 8/51 (15.7%) | 1/19 (5.3%) | ||
| Vomiting | 16/51 (31.4%) | 1/19 (5.3%) | ||
| General disorders | ||||
| Asthenia | 20/51 (39.2%) | 4/19 (21.1%) | ||
| Chest discomfort | 1/51 (2%) | 1/19 (5.3%) | ||
| Chest pain | 4/51 (7.8%) | 2/19 (10.5%) | ||
| Gravitational oedema | 0/51 (0%) | 1/19 (5.3%) | ||
| Influenza like illness | 9/51 (17.6%) | 1/19 (5.3%) | ||
| Oedema peripheral | 10/51 (19.6%) | 0/19 (0%) | ||
| Pyrexia | 31/51 (60.8%) | 9/19 (47.4%) | ||
| Infections and infestations | ||||
| Bronchitis | 12/51 (23.5%) | 1/19 (5.3%) | ||
| Cystitis | 4/51 (7.8%) | 2/19 (10.5%) | ||
| Dysentery | 1/51 (2%) | 1/19 (5.3%) | ||
| Ear infection | 3/51 (5.9%) | 2/19 (10.5%) | ||
| Fungal skin infection | 2/51 (3.9%) | 2/19 (10.5%) | ||
| Gastroenteritis | 9/51 (17.6%) | 2/19 (10.5%) | ||
| Hordeolum | 3/51 (5.9%) | 0/19 (0%) | ||
| Influenza | 25/51 (49%) | 7/19 (36.8%) | ||
| Localised infection | 1/51 (2%) | 1/19 (5.3%) | ||
| Nasopharyngitis | 17/51 (33.3%) | 5/19 (26.3%) | ||
| Oral herpes | 3/51 (5.9%) | 0/19 (0%) | ||
| Paronychia | 0/51 (0%) | 1/19 (5.3%) | ||
| Pharyngitis | 34/51 (66.7%) | 6/19 (31.6%) | ||
| Pharyngotonsillitis | 2/51 (3.9%) | 2/19 (10.5%) | ||
| Rhinitis | 29/51 (56.9%) | 7/19 (36.8%) | ||
| Sinusitis | 6/51 (11.8%) | 1/19 (5.3%) | ||
| Tonsillitis | 7/51 (13.7%) | 3/19 (15.8%) | ||
| Tooth abscess | 9/51 (17.6%) | 1/19 (5.3%) | ||
| Tooth infection | 0/51 (0%) | 1/19 (5.3%) | ||
| Tracheitis | 6/51 (11.8%) | 1/19 (5.3%) | ||
| Urinary tract infection | 7/51 (13.7%) | 3/19 (15.8%) | ||
| Vaginal infection | 6/51 (11.8%) | 0/19 (0%) | ||
| Vulvovaginal candidiasis | 0/51 (0%) | 1/19 (5.3%) | ||
| Vulvovaginal mycotic infection | 0/51 (0%) | 1/19 (5.3%) | ||
| Wound infection | 0/51 (0%) | 1/19 (5.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Limb injury | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Muscle strain | 1/51 (2%) | 1/19 (5.3%) | ||
| Neck injury | 0/51 (0%) | 2/19 (10.5%) | ||
| Pelvic fracture | 0/51 (0%) | 1/19 (5.3%) | ||
| Skeletal injury | 3/51 (5.9%) | 0/19 (0%) | ||
| Thermal burn | 1/51 (2%) | 1/19 (5.3%) | ||
| Transfusion reaction | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Investigations | ||||
| Beta 2 microglobulin increased | 6/51 (11.8%) | 0/19 (0%) | ||
| Beta 2 microglobulin urine increased | 4/51 (7.8%) | 0/19 (0%) | ||
| Blood folate decreased | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Blood phosphorus decreased | 0/51 (0%) | 1/19 (5.3%) | ||
| Blood thyroid stimulating hormone increased | 0/51 (0%) | 1/19 (5.3%) | ||
| Gamma-glutamyltransferase increased | 3/51 (5.9%) | 0/19 (0%) | ||
| Transaminases increased | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Vitamin C decreased | 8/51 (15.7%) | 1/19 (5.3%) | ||
| Vitamin E decreased | 4/51 (7.8%) | 0/19 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/51 (2%) | 1/19 (5.3%) | ||
| Hypocalcaemia | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Hypokalaemia | 3/51 (5.9%) | 1/19 (5.3%) | ||
| Metabolic acidosis | 0/51 (0%) | 1/19 (5.3%) | ||
| Zinc deficiency | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 16/51 (31.4%) | 2/19 (10.5%) | ||
| Back pain | 29/51 (56.9%) | 9/19 (47.4%) | ||
| Bone pain | 8/51 (15.7%) | 3/19 (15.8%) | ||
| Flank pain | 4/51 (7.8%) | 0/19 (0%) | ||
| Muscle spasms | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Musculoskeletal chest pain | 0/51 (0%) | 2/19 (10.5%) | ||
| Musculoskeletal pain | 7/51 (13.7%) | 0/19 (0%) | ||
| Myalgia | 3/51 (5.9%) | 0/19 (0%) | ||
| Neck pain | 7/51 (13.7%) | 0/19 (0%) | ||
| Osteoporosis | 3/51 (5.9%) | 3/19 (15.8%) | ||
| Pain in extremity | 10/51 (19.6%) | 2/19 (10.5%) | ||
| Torticollis | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Nervous system disorders | ||||
| Dizziness | 5/51 (9.8%) | 1/19 (5.3%) | ||
| Headache | 29/51 (56.9%) | 9/19 (47.4%) | ||
| Hypoaesthesia | 1/51 (2%) | 1/19 (5.3%) | ||
| Paraesthesia | 2/51 (3.9%) | 3/19 (15.8%) | ||
| Presyncope | 8/51 (15.7%) | 1/19 (5.3%) | ||
| Sciatica | 5/51 (9.8%) | 2/19 (10.5%) | ||
| Psychiatric disorders | ||||
| Anxiety | 4/51 (7.8%) | 0/19 (0%) | ||
| Depression | 4/51 (7.8%) | 0/19 (0%) | ||
| Insomnia | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Renal and urinary disorders | ||||
| Dysuria | 7/51 (13.7%) | 1/19 (5.3%) | ||
| Glycosuria | 1/51 (2%) | 1/19 (5.3%) | ||
| Micturition disorder | 0/51 (0%) | 1/19 (5.3%) | ||
| Nephrolithiasis | 5/51 (9.8%) | 0/19 (0%) | ||
| Nephropathy toxic | 1/51 (2%) | 2/19 (10.5%) | ||
| Nocturia | 0/51 (0%) | 1/19 (5.3%) | ||
| Pollakiuria | 0/51 (0%) | 2/19 (10.5%) | ||
| Proteinuria | 0/51 (0%) | 1/19 (5.3%) | ||
| Renal colic | 7/51 (13.7%) | 1/19 (5.3%) | ||
| Renal tubular disorder | 0/51 (0%) | 1/19 (5.3%) | ||
| Strangury | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Reproductive system and breast disorders | ||||
| Amenorrhoea | 4/51 (7.8%) | 1/19 (5.3%) | ||
| Dysmenorrhoea | 3/51 (5.9%) | 1/19 (5.3%) | ||
| Genital discharge | 1/51 (2%) | 1/19 (5.3%) | ||
| Genital haemorrhage | 0/51 (0%) | 2/19 (10.5%) | ||
| Pruritus genital | 0/51 (0%) | 1/19 (5.3%) | ||
| Vulvovaginal pruritus | 2/51 (3.9%) | 1/19 (5.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 3/51 (5.9%) | 0/19 (0%) | ||
| Cough | 36/51 (70.6%) | 7/19 (36.8%) | ||
| Nasal congestion | 1/51 (2%) | 1/19 (5.3%) | ||
| Oropharyngeal pain | 23/51 (45.1%) | 7/19 (36.8%) | ||
| Rhinitis allergic | 3/51 (5.9%) | 0/19 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 3/51 (5.9%) | 0/19 (0%) | ||
| Koilonychia | 0/51 (0%) | 1/19 (5.3%) | ||
| Pruritus | 5/51 (9.8%) | 2/19 (10.5%) | ||
| Rash | 2/51 (3.9%) | 3/19 (15.8%) | ||
| Rash papular | 1/51 (2%) | 1/19 (5.3%) | ||
| Skin lesion | 3/51 (5.9%) | 0/19 (0%) | ||
| Urticaria | 4/51 (7.8%) | 0/19 (0%) | ||
| Surgical and medical procedures | ||||
| Tooth extraction | 0/51 (0%) | 1/19 (5.3%) | ||
| Vascular disorders | ||||
| Hypotension | 5/51 (9.8%) | 2/19 (10.5%) | ||
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 (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862 778-8300 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01033747
Other Study ID Numbers:
- CICL670A0105E2
First Posted:
Dec 16, 2009
Last Update Posted:
Aug 11, 2011
Last Verified:
Jul 1, 2011