Trial Outcomes & Findings for An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload (NCT NCT00171210)
NCT ID: NCT00171210
Last Updated: 2011-05-30
Results Overview
Adverse events results are based on preferred terms with at least 7% of participants in any group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
506 participants
Primary outcome timeframe
up to 5 years
Results posted on
2011-05-30
Participant Flow
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).
Participant milestones
| Measure |
Crossover
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.
|
ICL670
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.
|
|---|---|---|
|
Overall Study
STARTED
|
259
|
296
|
|
Overall Study
STARTED EXTENSION STUDY
|
259
|
247
|
|
Overall Study
COMPLETED
|
190
|
181
|
|
Overall Study
NOT COMPLETED
|
69
|
115
|
Reasons for withdrawal
| Measure |
Crossover
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.
|
ICL670
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
27
|
|
Overall Study
Abnormal laboratory value(s)
|
6
|
3
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
11
|
15
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
32
|
30
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Administrative problems
|
1
|
1
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Stopped at end of core
|
0
|
32
|
|
Overall Study
Stopped at end of extension 1
|
0
|
1
|
Baseline Characteristics
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
Baseline characteristics by cohort
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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
n=555 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
18.3 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
17.1 years
STANDARD_DEVIATION 9.46 • n=7 Participants
|
17.7 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
225 participants
n=5 Participants
|
263 participants
n=7 Participants
|
488 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: 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.
Adverse events results are based on preferred terms with at least 7% of participants in any group.
Outcome measures
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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.
|
|---|---|---|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Urinary tract infection
|
14 Participants
|
23 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Urticaria
|
14 Participants
|
23 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Toothache
|
14 Participants
|
22 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Sinusitis
|
13 Participants
|
22 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Cholelithiasis
|
11 Participants
|
23 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Fatigue
|
22 Participants
|
29 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Pain in extremity
|
21 Participants
|
30 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Acute tonsillitis
|
21 Participants
|
29 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Dyspepsia
|
17 Participants
|
21 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Blood creatinine increased
|
22 Participants
|
47 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Pyrexia
|
109 Participants
|
113 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Cough
|
85 Participants
|
110 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Headache
|
81 Participants
|
84 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Diarrhoea
|
73 Participants
|
69 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Vomiting
|
61 Participants
|
75 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Gastroenteritis
|
31 Participants
|
37 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Influenza
|
65 Participants
|
70 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Abdominal pain
|
59 Participants
|
75 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Nasopharyngitis
|
56 Participants
|
73 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Nausea
|
52 Participants
|
63 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Oropharyngeal pain
|
50 Participants
|
62 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Pharyngitis
|
57 Participants
|
55 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Back Pain
|
49 Participants
|
59 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Abdominal pain upper
|
52 Participants
|
52 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Rhinitis
|
45 Participants
|
52 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Bronchitis
|
41 Participants
|
45 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Arthralgia
|
39 Participants
|
45 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Upper respiratory tract infection
|
32 Participants
|
52 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Transfusion reaction
|
36 Participants
|
34 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Asthenia
|
31 Participants
|
31 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Rash
|
24 Participants
|
34 Participants
|
|
Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
Tonsillitis
|
22 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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).
Outcome measures
| Measure |
Crossover
n=95 Participants
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.
|
ICL670
n=220 Participants
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.
|
|---|---|---|
|
Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy
|
-2.4 mg Fe/g dw
Standard Deviation 8.23
|
-4.1 mg Fe/g dw
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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).
Outcome measures
| Measure |
Crossover
n=34 Participants
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.
|
ICL670
n=44 Participants
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.
|
|---|---|---|
|
Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID
|
-0.5 mg Fe/g dw
Standard Deviation 5.34
|
-0.7 mg Fe/g dw
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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.
|
|---|---|---|
|
Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study
|
-122.1 μg/L
Standard Deviation 1406.77
|
-527.8 μg/L
Standard Deviation 1852.12
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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.
|
|---|---|---|
|
Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study
|
7.7 Percent change
Standard Deviation 16.3 • Interval -4.6 to 0.1
|
7.0 Percent change
Standard Deviation 14.78 • Interval -4.6 to 0.1
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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.
|
|---|---|---|
|
Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study
|
1.5 Percent change
Standard Deviation 29.99
|
10.3 Percent change
Standard Deviation 39.07
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=259 Participants
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.
|
ICL670
n=296 Participants
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.
|
|---|---|---|
|
Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study
|
-5.4 Percent change
Standard Deviation 27.06
|
3.4 Percent change
Standard Deviation 36.17
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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).
Outcome measures
| Measure |
Crossover
n=95 Participants
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.
|
ICL670
n=220 Participants
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.
|
|---|---|---|
|
Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy
|
-2.8 mg Fe/g dw
Full Range 8.23 • Interval -24.0 to 18.4
|
-3.2 mg Fe/g dw
Full Range 10.31 • Interval -34.7 to 31.4
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=95 Participants
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.
|
ICL670
n=220 Participants
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.
|
|---|---|---|
|
Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy
|
-25.4 percent of start value
Interval -97.6 to 314.6
|
-26.0 percent of start value
Interval -100.0 to 581.5
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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).
Outcome measures
| Measure |
Crossover
n=34 Participants
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.
|
ICL670
n=44 Participants
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.
|
|---|---|---|
|
Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID
|
-1.1 mg Fe/g dw
Interval -14.1 to 18.1
|
-1.6 mg Fe/g dw
Interval -8.7 to 12.0
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
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.
Outcome measures
| Measure |
Crossover
n=34 Participants
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.
|
ICL670
n=44 Participants
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.
|
|---|---|---|
|
Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID
|
-20.8 percent of start value
Interval -84.4 to 517.1
|
-33.0 percent of start value
Interval -87.0 to 218.2
|
SECONDARY outcome
Timeframe: Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)Population: 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.
Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.
Outcome measures
| Measure |
Crossover
n=129 Participants
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.
|
ICL670
n=266 Participants
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.
|
|---|---|---|
|
Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study
|
0.37 mg/kg/day
Interval 0.07 to 0.78
|
0.38 mg/kg/day
Interval -0.14 to 1.0
|
Adverse Events
ICL670
Serious events: 102 serious events
Other events: 266 other events
Deaths: 0 deaths
Crossover
Serious events: 61 serious events
Other events: 236 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICL670
n=296 participants at risk
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.
|
Crossover
n=259 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/296
|
0.77%
2/259
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.68%
2/296
|
0.00%
0/259
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/296
|
0.39%
1/259
|
|
Blood and lymphatic system disorders
Hypersplenism
|
2.7%
8/296
|
2.3%
6/259
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.34%
1/296
|
0.00%
0/259
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.34%
1/296
|
0.00%
0/259
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.34%
1/296
|
0.39%
1/259
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/296
|
0.39%
1/259
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.7%
5/296
|
0.39%
1/259
|
|
Cardiac disorders
Arrhythmia
|
0.68%
2/296
|
0.00%
0/259
|
|
Cardiac disorders
Atrial flutter
|
0.68%
2/296
|
0.00%
0/259
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/296
|
0.00%
0/259
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/296
|
0.00%
0/259
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/296
|
0.39%
1/259
|
|
Cardiac disorders
Cardiogenic shock
|
0.34%
1/296
|
0.00%
0/259
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
1/296
|
0.00%
0/259
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/296
|
0.39%
1/259
|
|
Cardiac disorders
Ventricular tachycardia
|
0.68%
2/296
|
0.00%
0/259
|
|
Congenital, familial and genetic disorders
Accessory spleen
|
0.00%
0/296
|
0.39%
1/259
|
|
Congenital, familial and genetic disorders
Thalassaemia beta
|
0.34%
1/296
|
0.39%
1/259
|
|
Ear and labyrinth disorders
Vertigo
|
0.34%
1/296
|
0.00%
0/259
|
|
Eye disorders
Cataract
|
0.34%
1/296
|
0.00%
0/259
|
|
Eye disorders
Lenticular opacities
|
0.34%
1/296
|
0.39%
1/259
|
|
Eye disorders
Papilloedema
|
0.00%
0/296
|
0.39%
1/259
|
|
Eye disorders
Vision blurred
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
8/296
|
1.5%
4/259
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.68%
2/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/296
|
0.77%
2/259
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
1/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Dyspepsia
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Ileus
|
0.34%
1/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Oesophagitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Pancreatitis
|
0.68%
2/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.68%
2/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.34%
1/296
|
0.00%
0/259
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/296
|
0.39%
1/259
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/296
|
0.00%
0/259
|
|
General disorders
Asthenia
|
1.0%
3/296
|
0.00%
0/259
|
|
General disorders
Chest pain
|
0.68%
2/296
|
0.00%
0/259
|
|
General disorders
Death
|
0.34%
1/296
|
0.00%
0/259
|
|
General disorders
Malaise
|
0.34%
1/296
|
0.00%
0/259
|
|
General disorders
Oedema peripheral
|
0.00%
0/296
|
0.39%
1/259
|
|
General disorders
Pain
|
0.34%
1/296
|
0.00%
0/259
|
|
General disorders
Pyrexia
|
3.4%
10/296
|
2.3%
6/259
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Biliary colic
|
0.34%
1/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.34%
1/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Cholangitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.34%
1/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
7/296
|
2.3%
6/259
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Hepatitis
|
0.68%
2/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.34%
1/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Jaundice
|
0.34%
1/296
|
0.00%
0/259
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.34%
1/296
|
0.39%
1/259
|
|
Hepatobiliary disorders
Liver injury
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Acute tonsillitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Appendicitis
|
0.34%
1/296
|
0.77%
2/259
|
|
Infections and infestations
Bronchitis
|
1.0%
3/296
|
0.00%
0/259
|
|
Infections and infestations
Bronchopneumonia
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Escherichia sepsis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/296
|
1.2%
3/259
|
|
Infections and infestations
Gastroenteritis viral
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Gastrointestinal infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
HIV infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/296
|
0.39%
1/259
|
|
Infections and infestations
Infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Infectious mononucleosis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Lower respiratory tract infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Lung abscess
|
0.00%
0/296
|
0.39%
1/259
|
|
Infections and infestations
Meningitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Meningitis bacterial
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Orchitis
|
0.00%
0/296
|
0.39%
1/259
|
|
Infections and infestations
Pharyngitis
|
0.68%
2/296
|
0.39%
1/259
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/296
|
0.39%
1/259
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/296
|
0.39%
1/259
|
|
Infections and infestations
Pneumonia
|
0.34%
1/296
|
0.39%
1/259
|
|
Infections and infestations
Pneumonia viral
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Pyelocystitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Pyelonephritis acute
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Septic shock
|
0.68%
2/296
|
0.00%
0/259
|
|
Infections and infestations
Sinusitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Tonsillitis
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Tooth abscess
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Upper respiratory tract infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Urinary tract infection
|
1.0%
3/296
|
0.00%
0/259
|
|
Infections and infestations
Viral infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Wound infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Infections and infestations
Yersinia infection
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/296
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/296
|
0.77%
2/259
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/296
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Head injury
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/296
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/296
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.68%
2/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.68%
2/296
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.34%
1/296
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.68%
2/296
|
0.00%
0/259
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Blood creatinine increased
|
0.34%
1/296
|
0.00%
0/259
|
|
Investigations
Blood potassium decreased
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Blood sodium decreased
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Cardiovascular function test abnormal
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Cells in urine
|
0.34%
1/296
|
0.00%
0/259
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Hepatic enzyme increased
|
0.34%
1/296
|
0.00%
0/259
|
|
Investigations
Liver function test abnormal
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Serum ferritin increased
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Streptococcal identification test positive
|
0.00%
0/296
|
0.39%
1/259
|
|
Investigations
Transaminases increased
|
1.0%
3/296
|
0.77%
2/259
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/296
|
0.39%
1/259
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
2/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
2/296
|
0.39%
1/259
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/296
|
0.39%
1/259
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/296
|
0.39%
1/259
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.34%
1/296
|
0.00%
0/259
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/296
|
0.39%
1/259
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.34%
1/296
|
0.00%
0/259
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myolipoma
|
0.00%
0/296
|
0.39%
1/259
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/296
|
0.39%
1/259
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Clumsiness
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Depressed level of consciousness
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Dizziness
|
0.68%
2/296
|
0.00%
0/259
|
|
Nervous system disorders
Epilepsy
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Headache
|
0.68%
2/296
|
0.00%
0/259
|
|
Nervous system disorders
Loss of consciousness
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.34%
1/296
|
0.00%
0/259
|
|
Nervous system disorders
Syncope
|
0.34%
1/296
|
0.00%
0/259
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.34%
1/296
|
0.00%
0/259
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/296
|
0.77%
2/259
|
|
Psychiatric disorders
Depression
|
0.34%
1/296
|
0.00%
0/259
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/296
|
0.39%
1/259
|
|
Psychiatric disorders
Insomnia
|
0.34%
1/296
|
0.00%
0/259
|
|
Psychiatric disorders
Suicide attempt
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/296
|
0.39%
1/259
|
|
Renal and urinary disorders
Calculus urinary
|
0.68%
2/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Glomerulonephropathy
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Hydronephrosis
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/296
|
0.39%
1/259
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
2/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Nephropathy
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Proteinuria
|
0.34%
1/296
|
0.39%
1/259
|
|
Renal and urinary disorders
Renal colic
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Renal failure
|
0.34%
1/296
|
0.00%
0/259
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/296
|
0.39%
1/259
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.34%
1/296
|
0.00%
0/259
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.34%
1/296
|
0.00%
0/259
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
1/296
|
0.39%
1/259
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.34%
1/296
|
0.00%
0/259
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.34%
1/296
|
0.00%
0/259
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/296
|
0.39%
1/259
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.34%
1/296
|
0.00%
0/259
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/296
|
0.39%
1/259
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/296
|
0.39%
1/259
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.34%
1/296
|
0.00%
0/259
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
2/296
|
0.00%
0/259
|
|
Surgical and medical procedures
Cholecystectomy
|
0.34%
1/296
|
0.00%
0/259
|
|
Surgical and medical procedures
Splenectomy
|
0.68%
2/296
|
0.39%
1/259
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
1/296
|
0.00%
0/259
|
|
Vascular disorders
Hypotension
|
0.34%
1/296
|
0.00%
0/259
|
Other adverse events
| Measure |
ICL670
n=296 participants at risk
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.
|
Crossover
n=259 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
5.7%
17/296
|
4.2%
11/259
|
|
Ear and labyrinth disorders
Ear pain
|
5.4%
16/296
|
5.4%
14/259
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
74/296
|
22.0%
57/259
|
|
Gastrointestinal disorders
Abdominal pain upper
|
17.2%
51/296
|
20.1%
52/259
|
|
Gastrointestinal disorders
Constipation
|
5.7%
17/296
|
5.0%
13/259
|
|
Gastrointestinal disorders
Diarrhoea
|
23.0%
68/296
|
28.2%
73/259
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
21/296
|
6.6%
17/259
|
|
Gastrointestinal disorders
Nausea
|
20.9%
62/296
|
20.1%
52/259
|
|
Gastrointestinal disorders
Toothache
|
7.4%
22/296
|
5.4%
14/259
|
|
Gastrointestinal disorders
Vomiting
|
24.3%
72/296
|
23.6%
61/259
|
|
General disorders
Asthenia
|
9.8%
29/296
|
12.0%
31/259
|
|
General disorders
Fatigue
|
9.8%
29/296
|
8.5%
22/259
|
|
General disorders
Influenza like illness
|
4.1%
12/296
|
6.6%
17/259
|
|
General disorders
Oedema peripheral
|
5.7%
17/296
|
5.8%
15/259
|
|
General disorders
Pyrexia
|
37.2%
110/296
|
41.7%
108/259
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.1%
18/296
|
1.9%
5/259
|
|
Infections and infestations
Acute tonsillitis
|
9.5%
28/296
|
8.1%
21/259
|
|
Infections and infestations
Bronchitis
|
14.2%
42/296
|
15.8%
41/259
|
|
Infections and infestations
Ear infection
|
7.4%
22/296
|
2.7%
7/259
|
|
Infections and infestations
Gastroenteritis
|
12.5%
37/296
|
11.2%
29/259
|
|
Infections and infestations
Influenza
|
23.6%
70/296
|
25.1%
65/259
|
|
Infections and infestations
Nasopharyngitis
|
24.7%
73/296
|
21.6%
56/259
|
|
Infections and infestations
Pharyngitis
|
18.2%
54/296
|
22.0%
57/259
|
|
Infections and infestations
Rhinitis
|
17.6%
52/296
|
17.4%
45/259
|
|
Infections and infestations
Sinusitis
|
7.1%
21/296
|
5.0%
13/259
|
|
Infections and infestations
Tonsillitis
|
9.8%
29/296
|
8.5%
22/259
|
|
Infections and infestations
Tooth abscess
|
5.1%
15/296
|
3.1%
8/259
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
52/296
|
12.4%
32/259
|
|
Infections and infestations
Urinary tract infection
|
7.8%
23/296
|
5.4%
14/259
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
10.8%
32/296
|
13.9%
36/259
|
|
Investigations
Blood creatinine increased
|
15.5%
46/296
|
8.5%
22/259
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.9%
44/296
|
15.1%
39/259
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.9%
59/296
|
18.9%
49/259
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
15/296
|
5.4%
14/259
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
15/296
|
1.5%
4/259
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.7%
17/296
|
5.8%
15/259
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
30/296
|
7.7%
20/259
|
|
Nervous system disorders
Headache
|
28.4%
84/296
|
31.3%
81/259
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.2%
110/296
|
32.8%
85/259
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
8/296
|
5.4%
14/259
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
10/296
|
5.4%
14/259
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.9%
62/296
|
19.3%
50/259
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
15/296
|
4.6%
12/259
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
33/296
|
9.3%
24/259
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.8%
23/296
|
5.4%
14/259
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER