Trial Outcomes & Findings for A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. (NCT NCT00390858)
NCT ID: NCT00390858
Last Updated: 2017-03-20
Results Overview
Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
4 year extension + core 1 year
Results posted on
2017-03-20
Participant Flow
Participant milestones
| Measure |
Children ( < 12 Years)
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Completed Core & Entered Extension Study
|
19
|
20
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Children ( < 12 Years)
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Baseline characteristics by cohort
| Measure |
Children (<12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.7 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
10.4 years
STANDARD_DEVIATION 4.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 year extension + core 1 yearPopulation: The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses.
Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.
Outcome measures
| Measure |
Children (<12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Infections & infestations
|
18 participants
|
17 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Skin & subcutaneous tissue disorders
|
12 participants
|
8 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Injury, poisoning & procedural complications
|
11 participants
|
8 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Ear & labyrinth disorders
|
9 participants
|
8 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Metabolism & nutrition disorders
|
6 participants
|
10 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Eye disorders
|
6 participants
|
9 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Renal & urinary disorders
|
3 participants
|
6 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Hepatobiliary disorders
|
1 participants
|
7 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Reproductive system & breast disorders
|
0 participants
|
8 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Cardiac disorders
|
1 participants
|
5 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Blood & lymphatic system disorders
|
1 participants
|
5 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Psychiatric disorders
|
2 participants
|
4 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Immune system disorders
|
0 participants
|
2 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Surgical & medical procedures
|
0 participants
|
3 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Endocrine disorders
|
1 participants
|
1 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Vascular disorders
|
0 participants
|
2 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Congenital, familial & genetic disorders
|
1 participants
|
0 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
General disorders & administration site conditions
|
19 participants
|
20 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Patients with at least one Adverse Event (AE)
|
20 participants
|
20 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Respiratory, thoracic & mediastinal disorders
|
19 participants
|
17 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Gastrointestinal disorders
|
18 participants
|
17 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Musculoskeletal & connective tissue disorders
|
12 participants
|
15 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Investigations
|
13 participants
|
10 participants
|
|
Participants With Adverse Events by Primary System Organ Class (SOC)
Nervous system disorders
|
9 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Baseline of Core Study to End of Extension Study, up to 5 years.Population: The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.
Change in Liver Iron Concentration \[LIC\] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)
Outcome measures
| Measure |
Children (<12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Change in Liver Iron Concentration (LIC)
Core Baseline LIC (n = 20, 20)
|
6.25 mg Fe/g dw
Standard Deviation 2.507
|
5.73 mg Fe/g dw
Standard Deviation 2.185
|
|
Change in Liver Iron Concentration (LIC)
End of Extension LIC (n=19, 20)
|
5.46 mg Fe/g dw
Standard Deviation 3.192
|
4.66 mg Fe/g dw
Standard Deviation 3.533
|
|
Change in Liver Iron Concentration (LIC)
Change from Baseline LIC (n=19, 20)
|
-0.9 mg Fe/g dw
Standard Deviation 3.85
|
-1.10 mg Fe/g dw
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline of Core Study to End of Extension Study, up to 5 yearsPopulation: The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.
Total Iron Body Elimination (TBIE) Rate \[mg/kg/Day\] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.
Outcome measures
| Measure |
Children (<12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)
Core Baseline TBIE (n=19, 20)
|
0.4292 mg/kg/Day
Standard Deviation 0.06454
|
0.4083 mg/kg/Day
Standard Deviation 0.07158
|
|
Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)
End of Extension TBIE (n=11,14)
|
0.4939 mg/kg/Day
Standard Deviation 0.05175
|
0.4286 mg/kg/Day
Standard Deviation 0.06370
|
SECONDARY outcome
Timeframe: Baseline of Core Study to Extension 18 months, up to 2.5 years.Population: The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.
Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.
Outcome measures
| Measure |
Children (<12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 Participants
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Relative Change in Serum Ferritin Level
|
62.4 percent change
Standard Deviation 53.47
|
54.9 percent change
Standard Deviation 64.64
|
Adverse Events
Children (<12 Years)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Adolescents ( ≧12 Years)
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Children (<12 Years)
n=20 participants at risk
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 participants at risk
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Local swelling
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Transaminases increased
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Surgical and medical procedures
Splenectomy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
Other adverse events
| Measure |
Children (<12 Years)
n=20 participants at risk
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
|
Adolescents ( ≧12 Years)
n=20 participants at risk
Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Congenital, familial and genetic disorders
Talipes
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Ear and labyrinth disorders
Auricular pseudocyst
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Ear and labyrinth disorders
Ear pain
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Endocrine disorders
Growth hormone deficiency
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Conjunctivitis
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Conjunctivitis allergic
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Eye irritation
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Hypermetropia
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Retinopathy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
15/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
50.0%
10/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Cheilitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Enteritis
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Intestinal congestion
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
50.0%
10/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
12/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Asthenia
|
35.0%
7/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Chest pain
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Cyst
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Hyperpyrexia
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Influenza like illness
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Pyrexia
|
90.0%
18/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
80.0%
16/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
General disorders
Suprapubic pain
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Immune system disorders
Allergy to plants
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Immune system disorders
Food allergy
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Bronchitis
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Catheter related infection
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Ear infection
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Fungal infection
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Gastroenteritis
|
50.0%
10/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Genital infection female
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Herpes simplex
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Impetigo
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Influenza
|
35.0%
7/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
55.0%
11/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Laryngitis
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Leptospirosis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Localised infection
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
6/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Oral herpes
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Pharyngitis
|
60.0%
12/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
50.0%
10/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Pharyngotonsillitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Pyoderma
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Rhinitis
|
85.0%
17/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
65.0%
13/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Subcutaneous abscess
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Tonsillitis
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Tooth abscess
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Tracheitis
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Varicella
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Infections and infestations
Vulvitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Chest injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Eye injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Limb injury
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Wound
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Beta 2 microglobulin urine increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Blood folate decreased
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Blood homocysteine increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Creatinine renal clearance decreased
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Glomerular filtration rate abnormal
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Glucose urine present
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Protein C decreased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Transaminases increased
|
40.0%
8/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Urinary casts
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
Vitamin E decreased
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Investigations
White blood cell count increased
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperinsulinism
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypozincaemia
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Vitamin C deficiency
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
5/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Headache
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
60.0%
12/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Psychiatric disorders
Nervousness
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
90.0%
18/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
80.0%
16/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
4/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
35.0%
7/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
45.0%
9/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.0%
3/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
10.0%
2/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
5.0%
1/20 • Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
|
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