Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00110617
Collaborator
(none)
212
59
2
35
3.6
0.1
Study Details
Study Description
Brief Summary
This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients With Iron Overload From Repeated Blood Transfusions
Study Start Date
:
May 1, 2005
Actual Primary Completion Date
:
Apr 1, 2008
Actual Study Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deferasirox (ICL670) Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. |
Drug: Deferasirox (ICL670)
Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
|
| Experimental: Deferoxamine (DFO) then ICL670 Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. |
Drug: Deferasirox (ICL670)
Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
Drug: Deferoxamine (DFO)
Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.
|
Outcome Measures
Primary Outcome Measures
- The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment [24 Weeks]
The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.
Secondary Outcome Measures
- Absolute Change in Serum Ferritin From Baseline to Week 24 [Baseline, 24 Weeks]
Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood.
- Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52 [Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks]
Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood.
- Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104 [Start of Deferasirox (ICL670) treatment, 104 Weeks]
Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age greater than or equal to 2 years
-
Male or female patients with sickle cell disease (SS, SC, SD, Sβo or Sβ+ thalassemia)
-
Iron overload from repeated blood transfusion, as defined by one of the following:
-
For patients > 16 years old receiving simple transfusions: lifetime history of receipt of at least 120 ml/kg or 30 adult units of packed red blood cells, OR
-
For patients ≤ 16 years old receiving simple transfusions: lifetime history of receipt of at least 120 ml/kg of packed red blood cells, OR
-
For all patients receiving exchange transfusions in the absence of a previous attempt to achieve negative iron balance: lifetime performance of at least 20 procedures, OR
-
For all patients: liver iron content ≥ 7 mg Fe/g dry weight as measured by biopsy, Magnetic Resonance Imaging (MRI), or magnetic susceptibility performed within 3 months prior to entry into screening
-
For entry into the screening period: serum ferritin of ≥ 1000 µg/mL on at least two occasions during the prior year obtained in the absence of concomitant infection.
-
Body weight > 10 kg
-
No known allergy or contraindication to the administration of deferoxamine
-
Ability to comply with all study-related procedures, medications, and evaluations
-
Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
-
Written informed consent by the patient or for pediatric patient's consent of the patient's legal guardian. The definition of the term 'pediatric' for enrollment and study conduct will be in accordance with the local legislation.
Exclusion Criteria:
-
Serum creatinine above the upper limit of normal
-
Significant proteinuria
-
History of nephrotic syndrome
-
Alanine aminotransferase (ALT) ≥ 250 U/L at screening
-
Clinical evidence of active hepatitis B or hepatitis C
-
History of HIV
-
Fever or other signs/symptoms of infection within 10 days prior to the screening visit
-
Uncontrolled systemic hypertension
-
History of Myocardial Infarction, Congestive Heart Failure or unstable cardiac disease not controlled by standard medical therapy
-
Clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation
-
Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug
-
History of drug or alcohol abuse within the 12 months prior to enrollment
-
Pregnant or breast feeding patients
-
Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug 7 days prior to the screening visit
-
Randomization in a previous clinical trial involving ICL670
Other protocol-related inclusion / exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Pediatric Hematology/Oncology | Birmingham | Alabama | United States | 35233 |
| 2 | University of Alabama Medical center | Birmingham | Alabama | United States | 35294 |
| 3 | University of South Alabama Medical Center | Mobile | Alabama | United States | 36604 |
| 4 | University of South Alabama | Mobile | Alabama | United States | 36617 |
| 5 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 6 | Children's Hospital Oakland | Oakland | California | United States | 94609 |
| 7 | Center for Cancer and Blood Disorders | Washington | District of Columbia | United States | 20010-2970 |
| 8 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 9 | Howard University Hospital | Washington | District of Columbia | United States | 20059 |
| 10 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 11 | Tampa Children's Hospital at St Joseph's | Tampa | Florida | United States | 33607-6387 |
| 12 | Tampa Children's Hospital at St. Joseph's | Tampa | Florida | United States | 33607-6387 |
| 13 | H. Lee Muffit Cancer Center and Research Institute/James A. Haley Veterans Hospital | Tampa | Florida | United States | 33612 |
| 14 | Emory University School of Medicine | Atlanta | Georgia | United States | 30303 |
| 15 | Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | United States | 30342 |
| 16 | Adult Sickle Cell Clinic | Augusta | Georgia | United States | 30912-3128 |
| 17 | Backus Children's Hospital | Savannah | Georgia | United States | 31403 |
| 18 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 19 | Children's Memorial Hospital | Chicago | Illinois | United States | 60614-3394 |
| 20 | Pediatric Sickle Cell Program/James Whitcomb Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 21 | St. Jude Children's Hospital Affiliate | Baton Rouge | Louisiana | United States | 70808 |
| 22 | Tulane University Sickle Cell Center | New Orleans | Louisiana | United States | 70112 |
| 23 | Children's Hospital | New Orleans | Louisiana | United States | 70118 |
| 24 | LSU Health Sciences Center/Carroll W. Feist Professor of Cancer Research | Shreveport | Louisiana | United States | 71130 |
| 25 | Brigham and Woman's Hospital/Harvard Medical School | Boston | Massachusetts | United States | 02115 |
| 26 | Children's Hospital Boston | Boston | Massachusetts | United States | 02115 |
| 27 | Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 28 | University of Michigan | Ann Arbor | Michigan | United States | 48109-0238 |
| 29 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 30 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
| 31 | Sickle Cell Center, Montefiore Hospital | Bronx | New York | United States | 10467-2490 |
| 32 | SUNY Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 33 | New York Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 34 | Weill Medical College of Cornell University | New York | New York | United States | 10021 |
| 35 | Columbia University | New York | New York | United States | 10032 |
| 36 | Carolinas Medical Transplant Center | Charlotte | North Carolina | United States | 28232 |
| 37 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
| 38 | Children's Hospital Medical Center | Cincinnati | Ohio | United States | 72764 |
| 39 | The University of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 40 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-4399 |
| 41 | Pennsylvania Oncology/Hematology | Philadelphia | Pennsylvania | United States | 19106 |
| 42 | Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 43 | Drexel University College of Medicine | Philadelphia | Pennsylvania | United States | 19134-1095 |
| 44 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 45 | Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 46 | Liberty Hematology Oncology Center | Columbia | South Carolina | United States | 29203 |
| 47 | Palmetto Health Clinical Trials | Columbia | South Carolina | United States | 29203 |
| 48 | Santee Hematology/Oncology | Sumter | South Carolina | United States | 29150 |
| 49 | St Jude's Children's Research Hospital | Memphis | Tennessee | United States | 38105-2794 |
| 50 | St. Jude's Children Research Hospital | Memphis | Tennessee | United States | 38105 |
| 51 | Cooks Children's Hospital | Fort Worth | Texas | United States | 76104-2724 |
| 52 | Texas Children's Hospital/Baylor College of Medicine | Houston | Texas | United States | 77030-2399 |
| 53 | Scott and White Memorial Hospital & Clinics | Temple | Texas | United States | 76508 |
| 54 | Children's Hospital of the King's Daughter | Norfolk | Virginia | United States | 23507 |
| 55 | Medical College of Virginia | Richmond | Virginia | United States | 23298-0306 |
| 56 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298-0646 |
| 57 | University of Alberta | Edmonton | Alberta | Canada | T6G 2H7 |
| 58 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 59 | Hopital Ste-Justine | Montreal | Quebec | Canada | H3T 1C5 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00110617
Other Study ID Numbers:
- CICL670A2201
First Posted:
May 11, 2005
Last Update Posted:
May 26, 2011
Last Verified:
May 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 212 participants were enrolled in the study; however, 9 participants from Site 512 were excluded due to severe Good Clinical Practice (GCP) violations. 203 participants are included in the Full Analysis Set 1. |
| Arm/Group Title | Deferasirox (ICL670) | Deferoxamine (DFO) Then ICL670 |
|---|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. | Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. |
| Period Title: Overall Study | ||
| STARTED | 135 | 68 |
| Safety Set 1; Received Study Drug | 135 | 56 |
| Full Analysis 2; Received ICL670 | 135 | 53 |
| On Going at Week 24 | 126 | 53 |
| COMPLETED | 96 | 39 |
| NOT COMPLETED | 39 | 29 |
Baseline Characteristics
| Arm/Group Title | Deferasirox (ICL670) | Deferoxamine (DFO) Then ICL670 | Total |
|---|---|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. | Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. | Total of all reporting groups |
| Overall Participants | 135 | 68 | 203 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
16.4
(10.31)
|
16.2
(10.15)
|
16.3
(10.23)
|
| Age, Customized (participants) [Number] | |||
| 2- < 6 Years |
6
4.4%
|
4
5.9%
|
10
4.9%
|
| 6- <12 Years |
42
31.1%
|
21
30.9%
|
63
31%
|
| 12- <16 Years |
35
25.9%
|
18
26.5%
|
53
26.1%
|
| 16- < 50 Years |
50
37%
|
24
35.3%
|
74
36.5%
|
| 50- <65 Years |
2
1.5%
|
1
1.5%
|
3
1.5%
|
| = 65 Years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
56
41.5%
|
33
48.5%
|
89
43.8%
|
| Male |
79
58.5%
|
35
51.5%
|
114
56.2%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| Caucasian |
2
1.5%
|
0
0%
|
2
1%
|
| Black |
130
96.3%
|
65
95.6%
|
195
96.1%
|
| Oriental |
0
0%
|
0
0%
|
0
0%
|
| Other |
3
2.2%
|
3
4.4%
|
6
3%
|
| Weight Group (Number) [Number] | |||
| <15 kg |
0
0%
|
0
0%
|
0
0%
|
| 15- <35 kg |
39
28.9%
|
23
33.8%
|
62
30.5%
|
| 35- < 55 kg |
43
31.9%
|
18
26.5%
|
61
30%
|
| 55- <75 kg |
42
31.1%
|
22
32.4%
|
64
31.5%
|
| =75 kg |
10
7.4%
|
3
4.4%
|
13
6.4%
|
| Missing |
1
0.7%
|
2
2.9%
|
3
1.5%
|
Outcome Measures
| Title | Absolute Change in Serum Ferritin From Baseline to Week 24 |
|---|---|
| Description | Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood. |
| Time Frame | Baseline, 24 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol- 1 defined as all participants who had study drug and had an assessment of serum ferritin at Baseline and at Week 24. |
| Arm/Group Title | Deferasirox (ICL670) | Deferoxamine (DFO) Then ICL670 |
|---|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. | Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. |
| Measure Participants | 117 | 50 |
| Least Squares Mean (95% Confidence Interval) [mg/mL] |
-173.2
|
-868.7
|
| Title | Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52 |
|---|---|
| Description | Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood. |
| Time Frame | Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol- 2 set defined as all participants who received study drug and had an assessment of serum ferritin at Start of ICL670 treatment and at 24 weeks or 52 weeks. |
| Arm/Group Title | Deferasirox (ICL670) | Deferoxamine (DFO) Then ICL670 |
|---|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. | Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. |
| Measure Participants | 113 | 49 |
| 24 weeks from ICL670 treatment start (n=111,47) |
-146.7
|
-204.7
|
| 52 weeks from ICL670 treatment start (n=113,40) |
-487.3
|
-545.7
|
| Title | The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment |
|---|---|
| Description | The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks. |
| Time Frame | 24 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety-1 set: All participants, except participants enrolled in Center 512, who received at least one dose of study medication during the first 24 weeks. |
| Arm/Group Title | Deferasirox (ICL670) | Deferoxamine (DFO) Then ICL670 |
|---|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. | Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. |
| Measure Participants | 135 | 56 |
| Headache |
30
22.2%
|
17
25%
|
| Sickle cell anaemia with crisis |
30
22.2%
|
8
11.8%
|
| Diarrhoea |
30
22.2%
|
5
7.4%
|
| Vomiting |
21
15.6%
|
9
13.2%
|
| Pyrexia |
19
14.1%
|
9
13.2%
|
| Nausea |
20
14.8%
|
4
5.9%
|
| Abdominal pain |
16
11.9%
|
6
8.8%
|
| Upper respiratory tract infection |
10
7.4%
|
9
13.2%
|
| Rash |
14
10.4%
|
3
4.4%
|
| Cough |
10
7.4%
|
7
10.3%
|
| Constipation |
11
8.1%
|
2
2.9%
|
| Pain in Extremity |
10
7.4%
|
3
4.4%
|
| Back Pain |
8
5.9%
|
4
5.9%
|
| Chest Pain |
7
5.2%
|
5
7.4%
|
| Oropharyngeal pain |
7
5.2%
|
5
7.4%
|
| Pruritus |
7
5.2%
|
5
7.4%
|
| Abdominal pain upper |
8
5.9%
|
3
4.4%
|
| Nasal congestion |
6
4.4%
|
4
5.9%
|
| Urinary tract infection |
9
6.7%
|
0
0%
|
| Arthralgia |
7
5.2%
|
1
1.5%
|
| Nasopharyngitis |
4
3%
|
3
4.4%
|
| Insomnia |
3
2.2%
|
3
4.4%
|
| Dizziness |
2
1.5%
|
3
4.4%
|
| Injection site pain |
0
0%
|
3
4.4%
|
| Title | Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104 |
|---|---|
| Description | Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood. |
| Time Frame | Start of Deferasirox (ICL670) treatment, 104 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol- 2 set defined as all participants who received study drug and had assessment of serum ferritin at Start of ICL670 treatment and at 104 weeks. |
| Arm/Group Title | Deferasirox (ICL670) |
|---|---|
| Arm/Group Description | Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. |
| Measure Participants | 87 |
| Least Squares Mean (95% Confidence Interval) [mg/mL] |
-682.6
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Period 1 Deferasirox (ICL670) | Period 1 Deferoxamine (DFO) | Period 2 Deferasirox (ICL670) | Period 2 Deferoxamine (DFO) Then ICL670 | ||||
| Arm/Group Description | Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily. | Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg. | Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily. | Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period. | ||||
All Cause Mortality |
||||||||
| Period 1 Deferasirox (ICL670) | Period 1 Deferoxamine (DFO) | Period 2 Deferasirox (ICL670) | Period 2 Deferoxamine (DFO) Then ICL670 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Period 1 Deferasirox (ICL670) | Period 1 Deferoxamine (DFO) | Period 2 Deferasirox (ICL670) | Period 2 Deferoxamine (DFO) Then ICL670 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/135 (29.6%) | 20/56 (35.7%) | 78/135 (57.8%) | 22/53 (41.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Acute chest syndrome | 0/135 (0%) | 2/56 (3.6%) | 2/135 (1.5%) | 1/53 (1.9%) | ||||
| Leukocytosis | 1/135 (0.7%) | 0/56 (0%) | 3/135 (2.2%) | 1/53 (1.9%) | ||||
| Cardiac disorders | ||||||||
| Cardio-respiratory arrest | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Conduction disorder | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Intracardiac thrombus | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Sickle cell anaemia | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Sickle cell anaemia with crisis | 27/135 (20%) | 6/56 (10.7%) | 38/135 (28.1%) | 11/53 (20.8%) | ||||
| Endocrine disorders | ||||||||
| Adrenocortical insufficiency acute | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Eye disorders | ||||||||
| Photophobia | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 2/135 (1.5%) | 0/56 (0%) | 6/135 (4.4%) | 1/53 (1.9%) | ||||
| Abdominal pain upper | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Diarrhoea | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 1/53 (1.9%) | ||||
| Inguinal hernia | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Nausea | 5/135 (3.7%) | 0/56 (0%) | 6/135 (4.4%) | 0/53 (0%) | ||||
| Small intestinal obstruction | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Vomiting | 4/135 (3%) | 0/56 (0%) | 7/135 (5.2%) | 1/53 (1.9%) | ||||
| General disorders | ||||||||
| Asthenia | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Catheter site pain | 0/135 (0%) | 1/56 (1.8%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Chest pain | 1/135 (0.7%) | 0/56 (0%) | 7/135 (5.2%) | 4/53 (7.5%) | ||||
| Chills | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Device breakage | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Device malfunction | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Implant site reaction | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Oedema peripheral | 1/135 (0.7%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Pain | 2/135 (1.5%) | 0/56 (0%) | 3/135 (2.2%) | 1/53 (1.9%) | ||||
| Pyrexia | 6/135 (4.4%) | 3/56 (5.4%) | 17/135 (12.6%) | 6/53 (11.3%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/135 (0%) | 1/56 (1.8%) | 3/135 (2.2%) | 1/53 (1.9%) | ||||
| Infections and infestations | ||||||||
| Bacteraemia | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 2/53 (3.8%) | ||||
| Bacterial infection | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Bronchitis | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Catheter site infection | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Cellulitis | 0/135 (0%) | 2/56 (3.6%) | 0/135 (0%) | 0/53 (0%) | ||||
| Device related infection | 1/135 (0.7%) | 0/56 (0%) | 3/135 (2.2%) | 0/53 (0%) | ||||
| Gastroenteritis | 1/135 (0.7%) | 0/56 (0%) | 3/135 (2.2%) | 1/53 (1.9%) | ||||
| Gastroenteritis viral | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Infected skin ulcer | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Lobar pneumonia | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Mycoplasma infection | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Parvovirus infection | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Pharyngitis | 0/135 (0%) | 0/56 (0%) | 3/135 (2.2%) | 0/53 (0%) | ||||
| Pharyngitis streptococcal | 1/135 (0.7%) | 1/56 (1.8%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Pneumonia | 4/135 (3%) | 0/56 (0%) | 9/135 (6.7%) | 4/53 (7.5%) | ||||
| Pneumonia klebsiella | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Pneumonia streptococcal | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Pyelonephritis | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Rotavirus infection | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Sepsis | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Septic shock | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Sinusitis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Staphylococcal bacteraemia | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Streptococcal infection | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Tooth abscess | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Upper respiratory tract infection | 0/135 (0%) | 2/56 (3.6%) | 4/135 (3%) | 1/53 (1.9%) | ||||
| Urinary tract infection | 2/135 (1.5%) | 0/56 (0%) | 4/135 (3%) | 1/53 (1.9%) | ||||
| Viral infection | 1/135 (0.7%) | 1/56 (1.8%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Clavicle fracture | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Fall | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Fibula fracture | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Humerus fracture | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Injury | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Patella fracture | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Procedural pain | 1/135 (0.7%) | 1/56 (1.8%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Road traffic accident | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Aspartate aminotransferase increased | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Blood culture positive | 2/135 (1.5%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Blood pressure diastolic decreased | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Culture throat positive | 1/135 (0.7%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Haemoglobin decreased | 0/135 (0%) | 1/56 (1.8%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Heart rate increased | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Hepatic enzyme increased | 2/135 (1.5%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Liver function test abnormal | 2/135 (1.5%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Oxygen saturation decreased | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Serum ferritin increased | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Urine protein/creatinine ratio increased | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| White blood cells urine positive | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Diabetes mellitus inadequate control | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Haemosiderosis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Hyperglycaemic hyperosmolar nonketotic syndrome | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Hyperkalaemia | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Type 2 diabetes mellitus | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Arthropathy | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Back pain | 1/135 (0.7%) | 1/56 (1.8%) | 2/135 (1.5%) | 1/53 (1.9%) | ||||
| Musculoskeletal pain | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Neck pain | 1/135 (0.7%) | 1/56 (1.8%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Osteonecrosis | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Pain in extremity | 2/135 (1.5%) | 0/56 (0%) | 5/135 (3.7%) | 0/53 (0%) | ||||
| Nervous system disorders | ||||||||
| Altered state of consciousness | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Ataxia | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Balance disorder | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Carotid artery occlusion | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Cerebral ischaemia | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Cerebrovascular accident | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Convulsion | 1/135 (0.7%) | 0/56 (0%) | 4/135 (3%) | 0/53 (0%) | ||||
| Dysarthria | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Headache | 2/135 (1.5%) | 2/56 (3.6%) | 5/135 (3.7%) | 1/53 (1.9%) | ||||
| Hypokinesia | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Loss of consciousness | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Migraine | 2/135 (1.5%) | 0/56 (0%) | 2/135 (1.5%) | 0/53 (0%) | ||||
| Moyamoya disease | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Nervous system disorder | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Syncope | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 1/53 (1.9%) | ||||
| Transient ischaemic attack | 2/135 (1.5%) | 0/56 (0%) | 2/135 (1.5%) | 1/53 (1.9%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Pregnancy | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Psychiatric disorders | ||||||||
| Confusional state | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Delirium | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Mental status changes | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Haematuria | 1/135 (0.7%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Nephrolithiasis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Renal failure acute | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Renal papillary necrosis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Bronchospasm | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Cough | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 2/53 (3.8%) | ||||
| Dyspnoea | 0/135 (0%) | 0/56 (0%) | 3/135 (2.2%) | 0/53 (0%) | ||||
| Epistaxis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Hypoxia | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Lung infiltration | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Oropharyngeal pain | 1/135 (0.7%) | 0/56 (0%) | 3/135 (2.2%) | 0/53 (0%) | ||||
| Pharyngeal inflammation | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Pneumonia aspiration | 0/135 (0%) | 1/56 (1.8%) | 0/135 (0%) | 0/53 (0%) | ||||
| Pulmonary embolism | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 2/53 (3.8%) | ||||
| Pulmonary oedema | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Wheezing | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Skin ulcer | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 0/53 (0%) | ||||
| Vascular disorders | ||||||||
| Poor peripheral circulation | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
| Superior vena caval occlusion | 0/135 (0%) | 0/56 (0%) | 0/135 (0%) | 1/53 (1.9%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Period 1 Deferasirox (ICL670) | Period 1 Deferoxamine (DFO) | Period 2 Deferasirox (ICL670) | Period 2 Deferoxamine (DFO) Then ICL670 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 91/135 (67.4%) | 39/56 (69.6%) | 118/135 (87.4%) | 44/53 (83%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Sickle cell anaemia with crisis | 7/135 (5.2%) | 4/56 (7.1%) | 17/135 (12.6%) | 7/53 (13.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/135 (0%) | 0/56 (0%) | 4/135 (3%) | 4/53 (7.5%) | ||||
| Abdominal pain | 14/135 (10.4%) | 6/56 (10.7%) | 30/135 (22.2%) | 8/53 (15.1%) | ||||
| Abdominal pain upper | 7/135 (5.2%) | 3/56 (5.4%) | 13/135 (9.6%) | 5/53 (9.4%) | ||||
| Constipation | 11/135 (8.1%) | 2/56 (3.6%) | 24/135 (17.8%) | 4/53 (7.5%) | ||||
| Diarrhoea | 30/135 (22.2%) | 5/56 (8.9%) | 36/135 (26.7%) | 9/53 (17%) | ||||
| Nausea | 16/135 (11.9%) | 4/56 (7.1%) | 33/135 (24.4%) | 10/53 (18.9%) | ||||
| Vomiting | 18/135 (13.3%) | 9/56 (16.1%) | 30/135 (22.2%) | 11/53 (20.8%) | ||||
| General disorders | ||||||||
| Chest pain | 6/135 (4.4%) | 5/56 (8.9%) | 16/135 (11.9%) | 9/53 (17%) | ||||
| Injection site pain | 0/135 (0%) | 3/56 (5.4%) | 0/135 (0%) | 0/53 (0%) | ||||
| Oedema peripheral | 0/135 (0%) | 0/56 (0%) | 7/135 (5.2%) | 1/53 (1.9%) | ||||
| Pain | 0/135 (0%) | 0/56 (0%) | 11/135 (8.1%) | 1/53 (1.9%) | ||||
| Pyrexia | 14/135 (10.4%) | 7/56 (12.5%) | 34/135 (25.2%) | 15/53 (28.3%) | ||||
| Immune system disorders | ||||||||
| Hypersensitivity | 0/135 (0%) | 0/56 (0%) | 7/135 (5.2%) | 3/53 (5.7%) | ||||
| Infections and infestations | ||||||||
| Gastroenteritis | 0/135 (0%) | 0/56 (0%) | 1/135 (0.7%) | 4/53 (7.5%) | ||||
| Influenza | 0/135 (0%) | 0/56 (0%) | 4/135 (3%) | 3/53 (5.7%) | ||||
| Nasopharyngitis | 4/135 (3%) | 3/56 (5.4%) | 18/135 (13.3%) | 6/53 (11.3%) | ||||
| Otitis media | 0/135 (0%) | 0/56 (0%) | 4/135 (3%) | 3/53 (5.7%) | ||||
| Pharyngitis streptococcal | 0/135 (0%) | 0/56 (0%) | 6/135 (4.4%) | 5/53 (9.4%) | ||||
| Pneumonia | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 4/53 (7.5%) | ||||
| Sinusitis | 0/135 (0%) | 0/56 (0%) | 9/135 (6.7%) | 2/53 (3.8%) | ||||
| Upper respiratory tract infection | 10/135 (7.4%) | 7/56 (12.5%) | 25/135 (18.5%) | 7/53 (13.2%) | ||||
| Urinary tract infection | 7/135 (5.2%) | 0/56 (0%) | 17/135 (12.6%) | 6/53 (11.3%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Transfusion reaction | 0/135 (0%) | 0/56 (0%) | 2/135 (1.5%) | 3/53 (5.7%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/135 (0%) | 0/56 (0%) | 7/135 (5.2%) | 1/53 (1.9%) | ||||
| Blood pressure diastolic increased | 0/135 (0%) | 0/56 (0%) | 8/135 (5.9%) | 1/53 (1.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 7/135 (5.2%) | 1/56 (1.8%) | 20/135 (14.8%) | 5/53 (9.4%) | ||||
| Back pain | 7/135 (5.2%) | 3/56 (5.4%) | 20/135 (14.8%) | 11/53 (20.8%) | ||||
| Musculoskeletal pain | 0/135 (0%) | 0/56 (0%) | 9/135 (6.7%) | 1/53 (1.9%) | ||||
| Pain in extremity | 10/135 (7.4%) | 3/56 (5.4%) | 31/135 (23%) | 9/53 (17%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 2/135 (1.5%) | 3/56 (5.4%) | 8/135 (5.9%) | 0/53 (0%) | ||||
| Headache | 28/135 (20.7%) | 15/56 (26.8%) | 47/135 (34.8%) | 13/53 (24.5%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 3/135 (2.2%) | 3/56 (5.4%) | 7/135 (5.2%) | 1/53 (1.9%) | ||||
| Renal and urinary disorders | ||||||||
| Dysuria | 0/135 (0%) | 0/56 (0%) | 7/135 (5.2%) | 2/53 (3.8%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 10/135 (7.4%) | 7/56 (12.5%) | 29/135 (21.5%) | 14/53 (26.4%) | ||||
| Dyspnoea | 0/135 (0%) | 0/56 (0%) | 7/135 (5.2%) | 2/53 (3.8%) | ||||
| Epistaxis | 0/135 (0%) | 0/56 (0%) | 8/135 (5.9%) | 1/53 (1.9%) | ||||
| Nasal congestion | 6/135 (4.4%) | 4/56 (7.1%) | 20/135 (14.8%) | 7/53 (13.2%) | ||||
| Oropharyngeal pain | 6/135 (4.4%) | 5/56 (8.9%) | 24/135 (17.8%) | 5/53 (9.4%) | ||||
| Rhinorrhoea | 0/135 (0%) | 0/56 (0%) | 9/135 (6.7%) | 2/53 (3.8%) | ||||
| Wheezing | 0/135 (0%) | 0/56 (0%) | 3/135 (2.2%) | 3/53 (5.7%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 7/135 (5.2%) | 5/56 (8.9%) | 13/135 (9.6%) | 2/53 (3.8%) | ||||
| Rash | 14/135 (10.4%) | 3/56 (5.4%) | 21/135 (15.6%) | 4/53 (7.5%) | ||||
Limitations/Caveats
Due to severe good clinical practice violations, data from 9 participants recruited for Center 512 was excluded from the main analysis of the study.
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:
NCT00110617
Other Study ID Numbers:
- CICL670A2201
First Posted:
May 11, 2005
Last Update Posted:
May 26, 2011
Last Verified:
May 1, 2011