An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00171210
Collaborator
(none)
506
49
1
10.3
Study Details
Study Description
Brief Summary
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.
The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
506 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload
Study Start Date
:
Oct 1, 2004
Actual Primary Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deferasirox All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight. |
Drug: Deferasirox
Tablets taken orally once a day.
|
Outcome Measures
Primary Outcome Measures
- Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event [up to 5 years]
Adverse events results are based on preferred terms with at least 7% of participants in any group.
Secondary Outcome Measures
- Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).
- Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).
- Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670.
- Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100.
- Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100.
- Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study. (Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100.
- Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).
- Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.
- Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).
- Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.
- Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study [Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)]
Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria
-
Patients who completed the 12-month core study (NCT00061750)
-
Female patients after menarche and who were sexually active, if they used double-barrier contraception, oral contraceptive plus barrier contraceptive, or had undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
-
Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation
Exclusion criteria
-
Pregnant or breast feeding patients
-
Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 2 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609-1809 |
| 3 | Stanford Hospital, Division of Oncology | Stanford | California | United States | 94305-5208 |
| 4 | Children's Memorial Hospital | Chicago | Illinois | United States | 60614 |
| 5 | Children's Hospital Boston, Dept of Hematology | Boston | Massachusetts | United States | 02115 |
| 6 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-4399 |
| 7 | Novartis Investigative Site | Buenos Aires | Argentina | ||
| 8 | Novartis Investigative Site | Cordoba | Argentina | ||
| 9 | Novartis Investigative Site | Bruxelles | Belgium | ||
| 10 | Novartis Investigative Site | Laken | Belgium | ||
| 11 | Novartis Investigative Site | Liege | Belgium | ||
| 12 | Novartis Investigative Site | Mons | Belgium | ||
| 13 | Novartis Investigative Site | Campinas | Brazil | ||
| 14 | Novartis Investigative Site | Sao Paolo | Brazil | ||
| 15 | Novartis Investigative Site | Montreal | Canada | ||
| 16 | Novartis Investigative Site | Toronto | Canada | ||
| 17 | Novartis Investigative Site | Creteil | France | ||
| 18 | Novartis Investigative Site | Marseille | France | ||
| 19 | Novartis Investigative Site | Paris | France | ||
| 20 | Novartis Investigative Site | Pierre-Benite | France | ||
| 21 | Novartis Investigative Site | Berlin | Germany | ||
| 22 | Novartis Investigative Site | Duesseldorf | Germany | ||
| 23 | Novartis Investigative Site | Frankfurt | Germany | ||
| 24 | Novartis Investigative Site | Hamburg | Germany | ||
| 25 | Novartis Investigative Site | Ulm | Germany | ||
| 26 | Novartis Investigative Site | Athens | Greece | ||
| 27 | Novartis Investigative Site | Ioannina | Greece | ||
| 28 | Novartis Investigative Site | Patras | Greece | ||
| 29 | Novartis Investigative Site | Thessaloniki | Greece | ||
| 30 | Novartis Investigative Site | Brindisi | Italy | ||
| 31 | Novartis Investigative Site | Cagliari | Italy | ||
| 32 | Novartis Investigative Site | Catania | Italy | ||
| 33 | Novartis Investigative Site | Ferrara | Italy | ||
| 34 | Novartis Investigative Site | Genova | Italy | ||
| 35 | Novartis Investigative Site | Milan | Italy | ||
| 36 | Novartis Investigative Site | Monza | Italy | ||
| 37 | Novartis Investigative Site | Naples | Italy | ||
| 38 | Novartis Investigative Site | Palermo | Italy | ||
| 39 | Novartis Investigative Site | Pavia | Italy | ||
| 40 | Novartis Investigative Site | Roma | Italy | ||
| 41 | Novartis Investigative Site | Sassari | Italy | ||
| 42 | Novartis Investigative Site | Siracusa | Italy | ||
| 43 | Novartis Investigative Site | Turin | Italy | ||
| 44 | Novartis Investigative Site | Tunis | Tunisia | ||
| 45 | Novartis Investigative Site | Adana | Turkey | ||
| 46 | Novartis Investigative Site | Isparta | Turkey | ||
| 47 | Novartis Investigative Site | Istanbul | Turkey | ||
| 48 | Novartis Investigative Site | Izmir | Turkey | ||
| 49 | Novartis Investigative Site | London | United Kingdom |
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:
NCT00171210
Other Study ID Numbers:
- CICL670A0107E1
First Posted:
Sep 15, 2005
Last Update Posted:
May 30, 2011
Last Verified:
May 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study is an extension of core study (NCT0061750). 555 participants were treated with Deferasirox (ICL670) in the core and/or extension study. In the core study, 296 participants were treated with ICL670 and 259 participants were treated with Deferoxamine(DFO). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Period Title: Overall Study | ||
| STARTED | 259 | 296 |
| STARTED EXTENSION STUDY | 259 | 247 |
| COMPLETED | 190 | 181 |
| NOT COMPLETED | 69 | 115 |
Baseline Characteristics
| Arm/Group Title | Crossover | ICL670 | Total |
|---|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. | Total of all reporting groups |
| Overall Participants | 259 | 296 | 555 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
18.3
(9.82)
|
17.1
(9.46)
|
17.7
(9.64)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
125
48.3%
|
156
52.7%
|
281
50.6%
|
| Male |
134
51.7%
|
140
47.3%
|
274
49.4%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Black or African American |
1
0.4%
|
2
0.7%
|
3
0.5%
|
| White |
225
86.9%
|
263
88.9%
|
488
87.9%
|
| Oriental |
10
3.9%
|
9
3%
|
19
3.4%
|
| Other |
23
8.9%
|
22
7.4%
|
45
8.1%
|
Outcome Measures
| Title | Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event |
|---|---|
| Description | Adverse events results are based on preferred terms with at least 7% of participants in any group. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 259 | 296 |
| Pyrexia |
109
42.1%
|
113
38.2%
|
| Cough |
85
32.8%
|
110
37.2%
|
| Headache |
81
31.3%
|
84
28.4%
|
| Diarrhoea |
73
28.2%
|
69
23.3%
|
| Vomiting |
61
23.6%
|
75
25.3%
|
| Influenza |
65
25.1%
|
70
23.6%
|
| Abdominal pain |
59
22.8%
|
75
25.3%
|
| Nasopharyngitis |
56
21.6%
|
73
24.7%
|
| Nausea |
52
20.1%
|
63
21.3%
|
| Oropharyngeal pain |
50
19.3%
|
62
20.9%
|
| Pharyngitis |
57
22%
|
55
18.6%
|
| Back Pain |
49
18.9%
|
59
19.9%
|
| Abdominal pain upper |
52
20.1%
|
52
17.6%
|
| Rhinitis |
45
17.4%
|
52
17.6%
|
| Bronchitis |
41
15.8%
|
45
15.2%
|
| Arthralgia |
39
15.1%
|
45
15.2%
|
| Upper respiratory tract infection |
32
12.4%
|
52
17.6%
|
| Transfusion reaction |
36
13.9%
|
34
11.5%
|
| Blood creatinine increased |
22
8.5%
|
47
15.9%
|
| Gastroenteritis |
31
12%
|
37
12.5%
|
| Asthenia |
31
12%
|
31
10.5%
|
| Rash |
24
9.3%
|
34
11.5%
|
| Tonsillitis |
22
8.5%
|
30
10.1%
|
| Fatigue |
22
8.5%
|
29
9.8%
|
| Pain in extremity |
21
8.1%
|
30
10.1%
|
| Acute tonsillitis |
21
8.1%
|
29
9.8%
|
| Dyspepsia |
17
6.6%
|
21
7.1%
|
| Urinary tract infection |
14
5.4%
|
23
7.8%
|
| Urticaria |
14
5.4%
|
23
7.8%
|
| Toothache |
14
5.4%
|
22
7.4%
|
| Sinusitis |
13
5%
|
22
7.4%
|
| Cholelithiasis |
11
4.2%
|
23
7.8%
|
| Title | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy |
|---|---|
| Description | Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw). |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 95 | 220 |
| Mean (Standard Deviation) [mg Fe/g dw] |
-2.4
(8.23)
|
-4.1
(10.31)
|
| Title | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID |
|---|---|
| Description | Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw). |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 34 | 44 |
| Mean (Standard Deviation) [mg Fe/g dw] |
-0.5
(5.34)
|
-0.7
(4.03)
|
| Title | Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study |
|---|---|
| Description | Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 259 | 296 |
| Mean (Standard Deviation) [μg/L] |
-122.1
(1406.77)
|
-527.8
(1852.12)
|
| Title | Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study |
|---|---|
| Description | Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 259 | 296 |
| Mean (Standard Deviation) [Percent change] |
7.7
(16.3)
|
7.0
(14.78)
|
| Title | Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study |
|---|---|
| Description | Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 259 | 296 |
| Mean (Standard Deviation) [Percent change] |
1.5
(29.99)
|
10.3
(39.07)
|
| Title | Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study |
|---|---|
| Description | Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study. (Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 259 | 296 |
| Mean (Standard Deviation) [Percent change] |
-5.4
(27.06)
|
3.4
(36.17)
|
| Title | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy |
|---|---|
| Description | Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw). |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 95 | 220 |
| Median (Full Range) [mg Fe/g dw] |
-2.8
(8.23)
|
-3.2
(10.31)
|
| Title | Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy |
|---|---|
| Description | Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 95 | 220 |
| Median (Full Range) [percent of start value] |
-25.4
|
-26.0
|
| Title | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID |
|---|---|
| Description | Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw). |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 34 | 44 |
| Median (Full Range) [mg Fe/g dw] |
-1.1
|
-1.6
|
| Title | Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID |
|---|---|
| Description | Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 34 | 44 |
| Median (Full Range) [percent of start value] |
-20.8
|
-33.0
|
| Title | Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study |
|---|---|
| Description | Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study. |
| Time Frame | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. |
| Arm/Group Title | Crossover | ICL670 |
|---|---|---|
| Arm/Group Description | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight. |
| Measure Participants | 129 | 266 |
| Median (Full Range) [mg/kg/day] |
0.37
|
0.38
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | ICL670 | Crossover | ||
| Arm/Group Description | Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight. | Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight. | ||
All Cause Mortality |
||||
| ICL670 | Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ICL670 | Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 102/296 (34.5%) | 61/259 (23.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/296 (0.3%) | 2/259 (0.8%) | ||
| Anaemia haemolytic autoimmune | 2/296 (0.7%) | 0/259 (0%) | ||
| Haemolysis | 0/296 (0%) | 1/259 (0.4%) | ||
| Hypersplenism | 8/296 (2.7%) | 6/259 (2.3%) | ||
| Leukopenia | 1/296 (0.3%) | 0/259 (0%) | ||
| Lymphadenopathy | 1/296 (0.3%) | 0/259 (0%) | ||
| Neutropenia | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Neutrophilia | 0/296 (0%) | 1/259 (0.4%) | ||
| Splenomegaly | 5/296 (1.7%) | 1/259 (0.4%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 2/296 (0.7%) | 0/259 (0%) | ||
| Atrial flutter | 2/296 (0.7%) | 0/259 (0%) | ||
| Cardiac failure | 1/296 (0.3%) | 0/259 (0%) | ||
| Cardiac failure congestive | 1/296 (0.3%) | 0/259 (0%) | ||
| Cardio-respiratory arrest | 0/296 (0%) | 1/259 (0.4%) | ||
| Cardiogenic shock | 1/296 (0.3%) | 0/259 (0%) | ||
| Myocardial infarction | 1/296 (0.3%) | 0/259 (0%) | ||
| Tachycardia | 0/296 (0%) | 1/259 (0.4%) | ||
| Ventricular tachycardia | 2/296 (0.7%) | 0/259 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Accessory spleen | 0/296 (0%) | 1/259 (0.4%) | ||
| Thalassaemia beta | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/296 (0.3%) | 0/259 (0%) | ||
| Eye disorders | ||||
| Cataract | 1/296 (0.3%) | 0/259 (0%) | ||
| Lenticular opacities | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Papilloedema | 0/296 (0%) | 1/259 (0.4%) | ||
| Vision blurred | 1/296 (0.3%) | 0/259 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 8/296 (2.7%) | 4/259 (1.5%) | ||
| Abdominal pain lower | 0/296 (0%) | 1/259 (0.4%) | ||
| Abdominal pain upper | 2/296 (0.7%) | 0/259 (0%) | ||
| Acute abdomen | 0/296 (0%) | 2/259 (0.8%) | ||
| Appendicitis perforated | 0/296 (0%) | 1/259 (0.4%) | ||
| Colitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Diarrhoea | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Duodenal ulcer | 1/296 (0.3%) | 0/259 (0%) | ||
| Dyspepsia | 1/296 (0.3%) | 0/259 (0%) | ||
| Gastric ulcer | 1/296 (0.3%) | 0/259 (0%) | ||
| Gastrointestinal haemorrhage | 0/296 (0%) | 1/259 (0.4%) | ||
| Ileus | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Ileus paralytic | 0/296 (0%) | 1/259 (0.4%) | ||
| Inguinal hernia | 1/296 (0.3%) | 0/259 (0%) | ||
| Nausea | 1/296 (0.3%) | 0/259 (0%) | ||
| Oesophagitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Pancreatitis | 2/296 (0.7%) | 0/259 (0%) | ||
| Pancreatitis acute | 1/296 (0.3%) | 0/259 (0%) | ||
| Peptic ulcer | 2/296 (0.7%) | 0/259 (0%) | ||
| Peritoneal haemorrhage | 1/296 (0.3%) | 0/259 (0%) | ||
| Peritonitis | 0/296 (0%) | 1/259 (0.4%) | ||
| Varices oesophageal | 0/296 (0%) | 1/259 (0.4%) | ||
| Vomiting | 4/296 (1.4%) | 0/259 (0%) | ||
| General disorders | ||||
| Asthenia | 3/296 (1%) | 0/259 (0%) | ||
| Chest pain | 2/296 (0.7%) | 0/259 (0%) | ||
| Death | 1/296 (0.3%) | 0/259 (0%) | ||
| Malaise | 1/296 (0.3%) | 0/259 (0%) | ||
| Oedema peripheral | 0/296 (0%) | 1/259 (0.4%) | ||
| Pain | 1/296 (0.3%) | 0/259 (0%) | ||
| Pyrexia | 10/296 (3.4%) | 6/259 (2.3%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 0/296 (0%) | 1/259 (0.4%) | ||
| Biliary colic | 1/296 (0.3%) | 0/259 (0%) | ||
| Biliary tract disorder | 1/296 (0.3%) | 0/259 (0%) | ||
| Cholangitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Cholecystitis | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Cholecystitis acute | 1/296 (0.3%) | 0/259 (0%) | ||
| Cholecystitis chronic | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Cholelithiasis | 7/296 (2.4%) | 6/259 (2.3%) | ||
| Cholestasis | 0/296 (0%) | 1/259 (0.4%) | ||
| Hepatitis | 2/296 (0.7%) | 0/259 (0%) | ||
| Hepatitis acute | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Jaundice | 1/296 (0.3%) | 0/259 (0%) | ||
| Jaundice cholestatic | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Liver injury | 1/296 (0.3%) | 0/259 (0%) | ||
| Infections and infestations | ||||
| Acute tonsillitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Appendicitis | 1/296 (0.3%) | 2/259 (0.8%) | ||
| Bronchitis | 3/296 (1%) | 0/259 (0%) | ||
| Bronchopneumonia | 1/296 (0.3%) | 0/259 (0%) | ||
| Escherichia sepsis | 1/296 (0.3%) | 0/259 (0%) | ||
| Gastroenteritis | 1/296 (0.3%) | 3/259 (1.2%) | ||
| Gastroenteritis viral | 1/296 (0.3%) | 0/259 (0%) | ||
| Gastrointestinal infection | 1/296 (0.3%) | 0/259 (0%) | ||
| HIV infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Hepatitis C | 0/296 (0%) | 1/259 (0.4%) | ||
| Infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Infectious mononucleosis | 1/296 (0.3%) | 0/259 (0%) | ||
| Lower respiratory tract infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Lung abscess | 0/296 (0%) | 1/259 (0.4%) | ||
| Meningitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Meningitis bacterial | 1/296 (0.3%) | 0/259 (0%) | ||
| Orchitis | 0/296 (0%) | 1/259 (0.4%) | ||
| Pharyngitis | 2/296 (0.7%) | 1/259 (0.4%) | ||
| Pharyngitis streptococcal | 0/296 (0%) | 1/259 (0.4%) | ||
| Pilonidal cyst | 0/296 (0%) | 1/259 (0.4%) | ||
| Pneumonia | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Pneumonia viral | 1/296 (0.3%) | 0/259 (0%) | ||
| Pyelocystitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Pyelonephritis acute | 1/296 (0.3%) | 0/259 (0%) | ||
| Septic shock | 2/296 (0.7%) | 0/259 (0%) | ||
| Sinusitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Streptococcal bacteraemia | 1/296 (0.3%) | 0/259 (0%) | ||
| Tonsillitis | 1/296 (0.3%) | 0/259 (0%) | ||
| Tooth abscess | 1/296 (0.3%) | 0/259 (0%) | ||
| Upper respiratory tract infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Urinary tract infection | 3/296 (1%) | 0/259 (0%) | ||
| Viral infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Wound infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Yersinia infection | 1/296 (0.3%) | 0/259 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/296 (0%) | 1/259 (0.4%) | ||
| Cervical vertebral fracture | 1/296 (0.3%) | 0/259 (0%) | ||
| Femoral neck fracture | 1/296 (0.3%) | 0/259 (0%) | ||
| Femur fracture | 1/296 (0.3%) | 2/259 (0.8%) | ||
| Foot fracture | 0/296 (0%) | 1/259 (0.4%) | ||
| Head injury | 1/296 (0.3%) | 0/259 (0%) | ||
| Heat stroke | 1/296 (0.3%) | 0/259 (0%) | ||
| Jaw fracture | 1/296 (0.3%) | 0/259 (0%) | ||
| Ligament rupture | 0/296 (0%) | 1/259 (0.4%) | ||
| Limb injury | 1/296 (0.3%) | 0/259 (0%) | ||
| Lower limb fracture | 0/296 (0%) | 1/259 (0.4%) | ||
| Post procedural haemorrhage | 1/296 (0.3%) | 0/259 (0%) | ||
| Procedural pain | 2/296 (0.7%) | 0/259 (0%) | ||
| Road traffic accident | 2/296 (0.7%) | 1/259 (0.4%) | ||
| Tendon rupture | 1/296 (0.3%) | 0/259 (0%) | ||
| Transfusion reaction | 2/296 (0.7%) | 0/259 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 0/296 (0%) | 1/259 (0.4%) | ||
| Blood creatinine increased | 1/296 (0.3%) | 0/259 (0%) | ||
| Blood potassium decreased | 0/296 (0%) | 1/259 (0.4%) | ||
| Blood sodium decreased | 0/296 (0%) | 1/259 (0.4%) | ||
| Cardiovascular function test abnormal | 0/296 (0%) | 1/259 (0.4%) | ||
| Cells in urine | 1/296 (0.3%) | 0/259 (0%) | ||
| Haemoglobin decreased | 0/296 (0%) | 1/259 (0.4%) | ||
| Hepatic enzyme increased | 1/296 (0.3%) | 0/259 (0%) | ||
| Liver function test abnormal | 0/296 (0%) | 1/259 (0.4%) | ||
| Serum ferritin increased | 0/296 (0%) | 1/259 (0.4%) | ||
| Streptococcal identification test positive | 0/296 (0%) | 1/259 (0.4%) | ||
| Transaminases increased | 3/296 (1%) | 2/259 (0.8%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 0/296 (0%) | 1/259 (0.4%) | ||
| Diabetes mellitus | 1/296 (0.3%) | 0/259 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/296 (0.7%) | 0/259 (0%) | ||
| Back pain | 2/296 (0.7%) | 1/259 (0.4%) | ||
| Bone cyst | 1/296 (0.3%) | 0/259 (0%) | ||
| Bone lesion | 1/296 (0.3%) | 0/259 (0%) | ||
| Bone pain | 1/296 (0.3%) | 0/259 (0%) | ||
| Osteonecrosis | 0/296 (0%) | 1/259 (0.4%) | ||
| Osteoporotic fracture | 1/296 (0.3%) | 0/259 (0%) | ||
| Pain in extremity | 0/296 (0%) | 1/259 (0.4%) | ||
| Pathological fracture | 1/296 (0.3%) | 0/259 (0%) | ||
| Rheumatoid arthritis | 0/296 (0%) | 1/259 (0.4%) | ||
| Spinal osteoarthritis | 1/296 (0.3%) | 0/259 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Myolipoma | 0/296 (0%) | 1/259 (0.4%) | ||
| Pituitary tumour benign | 1/296 (0.3%) | 0/259 (0%) | ||
| Nervous system disorders | ||||
| Cerebral haemorrhage | 1/296 (0.3%) | 0/259 (0%) | ||
| Cerebral ischaemia | 0/296 (0%) | 1/259 (0.4%) | ||
| Cerebrovascular disorder | 1/296 (0.3%) | 0/259 (0%) | ||
| Clumsiness | 1/296 (0.3%) | 0/259 (0%) | ||
| Depressed level of consciousness | 1/296 (0.3%) | 0/259 (0%) | ||
| Dizziness | 2/296 (0.7%) | 0/259 (0%) | ||
| Epilepsy | 1/296 (0.3%) | 0/259 (0%) | ||
| Headache | 2/296 (0.7%) | 0/259 (0%) | ||
| Loss of consciousness | 1/296 (0.3%) | 0/259 (0%) | ||
| Psychomotor hyperactivity | 1/296 (0.3%) | 0/259 (0%) | ||
| Syncope | 1/296 (0.3%) | 0/259 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/296 (0.3%) | 0/259 (0%) | ||
| Pregnancy | 0/296 (0%) | 2/259 (0.8%) | ||
| Psychiatric disorders | ||||
| Depression | 1/296 (0.3%) | 0/259 (0%) | ||
| Dysthymic disorder | 0/296 (0%) | 1/259 (0.4%) | ||
| Insomnia | 1/296 (0.3%) | 0/259 (0%) | ||
| Suicide attempt | 1/296 (0.3%) | 0/259 (0%) | ||
| Renal and urinary disorders | ||||
| Calculus ureteric | 0/296 (0%) | 1/259 (0.4%) | ||
| Calculus urinary | 2/296 (0.7%) | 0/259 (0%) | ||
| Glomerulonephropathy | 1/296 (0.3%) | 0/259 (0%) | ||
| Hydronephrosis | 1/296 (0.3%) | 0/259 (0%) | ||
| Ketonuria | 0/296 (0%) | 1/259 (0.4%) | ||
| Nephrolithiasis | 2/296 (0.7%) | 0/259 (0%) | ||
| Nephropathy | 1/296 (0.3%) | 0/259 (0%) | ||
| Proteinuria | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Renal colic | 1/296 (0.3%) | 0/259 (0%) | ||
| Renal failure | 1/296 (0.3%) | 0/259 (0%) | ||
| Renal tubular disorder | 0/296 (0%) | 1/259 (0.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/296 (0.3%) | 0/259 (0%) | ||
| Cough | 1/296 (0.3%) | 0/259 (0%) | ||
| Dyspnoea | 1/296 (0.3%) | 1/259 (0.4%) | ||
| Lung disorder | 1/296 (0.3%) | 0/259 (0%) | ||
| Wheezing | 1/296 (0.3%) | 0/259 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermal cyst | 0/296 (0%) | 1/259 (0.4%) | ||
| Dermatitis allergic | 1/296 (0.3%) | 0/259 (0%) | ||
| Dyshidrosis | 0/296 (0%) | 1/259 (0.4%) | ||
| Henoch-Schonlein purpura | 0/296 (0%) | 1/259 (0.4%) | ||
| Hyperhidrosis | 1/296 (0.3%) | 0/259 (0%) | ||
| Rash | 2/296 (0.7%) | 0/259 (0%) | ||
| Surgical and medical procedures | ||||
| Cholecystectomy | 1/296 (0.3%) | 0/259 (0%) | ||
| Splenectomy | 2/296 (0.7%) | 1/259 (0.4%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 1/296 (0.3%) | 0/259 (0%) | ||
| Hypotension | 1/296 (0.3%) | 0/259 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ICL670 | Crossover | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 266/296 (89.9%) | 236/259 (91.1%) | ||
| Cardiac disorders | ||||
| Palpitations | 17/296 (5.7%) | 11/259 (4.2%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 16/296 (5.4%) | 14/259 (5.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 74/296 (25%) | 57/259 (22%) | ||
| Abdominal pain upper | 51/296 (17.2%) | 52/259 (20.1%) | ||
| Constipation | 17/296 (5.7%) | 13/259 (5%) | ||
| Diarrhoea | 68/296 (23%) | 73/259 (28.2%) | ||
| Dyspepsia | 21/296 (7.1%) | 17/259 (6.6%) | ||
| Nausea | 62/296 (20.9%) | 52/259 (20.1%) | ||
| Toothache | 22/296 (7.4%) | 14/259 (5.4%) | ||
| Vomiting | 72/296 (24.3%) | 61/259 (23.6%) | ||
| General disorders | ||||
| Asthenia | 29/296 (9.8%) | 31/259 (12%) | ||
| Fatigue | 29/296 (9.8%) | 22/259 (8.5%) | ||
| Influenza like illness | 12/296 (4.1%) | 17/259 (6.6%) | ||
| Oedema peripheral | 17/296 (5.7%) | 15/259 (5.8%) | ||
| Pyrexia | 110/296 (37.2%) | 108/259 (41.7%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 18/296 (6.1%) | 5/259 (1.9%) | ||
| Infections and infestations | ||||
| Acute tonsillitis | 28/296 (9.5%) | 21/259 (8.1%) | ||
| Bronchitis | 42/296 (14.2%) | 41/259 (15.8%) | ||
| Ear infection | 22/296 (7.4%) | 7/259 (2.7%) | ||
| Gastroenteritis | 37/296 (12.5%) | 29/259 (11.2%) | ||
| Influenza | 70/296 (23.6%) | 65/259 (25.1%) | ||
| Nasopharyngitis | 73/296 (24.7%) | 56/259 (21.6%) | ||
| Pharyngitis | 54/296 (18.2%) | 57/259 (22%) | ||
| Rhinitis | 52/296 (17.6%) | 45/259 (17.4%) | ||
| Sinusitis | 21/296 (7.1%) | 13/259 (5%) | ||
| Tonsillitis | 29/296 (9.8%) | 22/259 (8.5%) | ||
| Tooth abscess | 15/296 (5.1%) | 8/259 (3.1%) | ||
| Upper respiratory tract infection | 52/296 (17.6%) | 32/259 (12.4%) | ||
| Urinary tract infection | 23/296 (7.8%) | 14/259 (5.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Transfusion reaction | 32/296 (10.8%) | 36/259 (13.9%) | ||
| Investigations | ||||
| Blood creatinine increased | 46/296 (15.5%) | 22/259 (8.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 44/296 (14.9%) | 39/259 (15.1%) | ||
| Back pain | 59/296 (19.9%) | 49/259 (18.9%) | ||
| Bone pain | 15/296 (5.1%) | 14/259 (5.4%) | ||
| Musculoskeletal pain | 15/296 (5.1%) | 4/259 (1.5%) | ||
| Osteoporosis | 17/296 (5.7%) | 15/259 (5.8%) | ||
| Pain in extremity | 30/296 (10.1%) | 20/259 (7.7%) | ||
| Nervous system disorders | ||||
| Headache | 84/296 (28.4%) | 81/259 (31.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 110/296 (37.2%) | 85/259 (32.8%) | ||
| Epistaxis | 8/296 (2.7%) | 14/259 (5.4%) | ||
| Nasal congestion | 10/296 (3.4%) | 14/259 (5.4%) | ||
| Oropharyngeal pain | 62/296 (20.9%) | 50/259 (19.3%) | ||
| Productive cough | 15/296 (5.1%) | 12/259 (4.6%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 33/296 (11.1%) | 24/259 (9.3%) | ||
| Urticaria | 23/296 (7.8%) | 14/259 (5.4%) | ||
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:
NCT00171210
Other Study ID Numbers:
- CICL670A0107E1
First Posted:
Sep 15, 2005
Last Update Posted:
May 30, 2011
Last Verified:
May 1, 2011