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Trial record 9 of 231 for:    "essential thrombocythemia"

Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

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ClinicalTrials.gov Identifier: NCT01467661
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : June 8, 2016
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Essential Thrombocythemia (ET)
Intervention Drug: SPD422 (anagrelide hydrochloride)
Enrollment 41
Recruitment Details The study was conducted in 15 centers in the Japan between 27 October 2010 and 01 May 2015.
Pre-assignment Details Overall 53 participants were enrolled in study SPD422-308 (NCT01214915), 42 of them completed the study. Of these 42 participants, 41 entered in to the current extension study SPD422-309 (NCT01467661) with 33 of 41 participants entered the post marketing trial and 32 participants completed the study (after marketing approval was granted).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Period Title: Overall Study
Started 53 [1]
Completed SPD422-308 (NCT01214915) 42
Started SPD422-309 (NCT01467661) 41
Started Post Marketing Trial 33
Completed 32 [2]
Not Completed 21
Reason Not Completed
Adverse Event             16
Withdrawal by Subject             1
Lack of Efficacy             3
Not enrolled to SPD422-309 (NCT01467661)             1
[1]
Started Study SPD422-308 (NCT01214915)
[2]
Completed study SPD422-309 (NCT01467661)
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
61.6  (13.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
30
  56.6%
Male
23
  43.4%
1.Primary Outcome
Title Change From Baseline in Platelet Count at Final Assessment
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Time Frame Baseline and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets per liter (10^9/L)
Baseline 1021.6  (433.14)
Change at Final assessment -346.2  (638.35)
2.Primary Outcome
Title Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Time Frame Baseline and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets per liter (10^9/L)
Baseline (n = 33) 1088.3  (486.33)
Change at Final assessment (n = 31) -647.9  (514.89)
3.Primary Outcome
Title Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.
Time Frame Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n = 53) 11.3
Week 1 (n = 53) 17.0
Month 1 (n = 49) 42.9
Month 2 (n = 48) 50.0
Month 3 (n = 46) 54.3
Month 4 (n = 45) 60.0
Month 5 (n = 45) 66.7
Month 6 (n = 44) 65.9
Month 7 (n = 43) 67.4
Month 8 (n = 43) 72.1
Month 9 (n = 43) 69.8
Month 10 (n = 43) 69.8
Month 11 (n = 42) 69.0
Month 12 (n = 42) 69.0
Month 15 (n = 41) 75.6
Month 18 (n = 41) 78.0
Month 21 (n = 40) 77.5
Month 24 (n = 38) 78.9
Month 27 (n = 38) 81.6
Month 30 (n = 37) 75.7
Month 33 (n = 36) 72.2
Month 36 (n = 36) 83.3
Month 39 (n = 33) 81.8
Month 42 (n = 26) 73.1
Month 45 (n = 16) 68.8
Month 48 (n = 11) 81.8
Final Assessment (n = 53) 60.4
4.Primary Outcome
Title Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.
Time Frame Baseline and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n = 33) 12.1
Final Assessment (n = 31) 80.6
5.Primary Outcome
Title Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.
Time Frame Baseline and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
FA: Platelet count <600 to <600 (n=6) 9.4
FA: Platelet count <600 to >=600 (n=6) 1.9
FA: Platelet count >=600 to <600 (n=47) 50.9
FA: Platelet count >=600 to >=600 (n=47) 37.7
6.Primary Outcome
Title Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
Hide Description Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.
Time Frame Baseline and final assessment (within 5 days of the last dose of investigational product)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
FA: Platelet count <600 to <600 (n = 3) 9.7
FA: Platelet count <600 to >=600 (n = 3) 0.0
FA: Platelet count >=600 to <600 (n = 28) 71.0
FA: Platelet count >=600 to >=600 (n = 28) 19.4
7.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 100
Participants with TESAEs 39.6
8.Primary Outcome
Title Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 39.4
Participants with TESAEs 3.0
9.Primary Outcome
Title Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 73.6
Participants with TESAEs 1.9
10.Primary Outcome
Title Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 0
Participants with TESAEs 0
11.Primary Outcome
Title Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 5.7
Participants with TESAEs 0
12.Primary Outcome
Title Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
Participants with TEAEs 3.0
Participants with TESAEs 0
13.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide Description Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
Time Frame From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
Arm/Group Title SPD422 (Anagrelide Hydrochloride)
Hide Arm/Group Description:
Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
11
Time Frame From start of study treatment (SPD422308) up to 12 days after the last dose of investigational product
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPD422: Safety Analysis Set SPD422: Post-marketing Trial Safety Analysis Set
Hide Arm/Group Description Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
All-Cause Mortality
SPD422: Safety Analysis Set SPD422: Post-marketing Trial Safety Analysis Set
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SPD422: Safety Analysis Set SPD422: Post-marketing Trial Safety Analysis Set
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/53 (39.62%)      1/33 (3.03%)    
Blood and lymphatic system disorders     
Leukocytosis * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SPLENOMEGALY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Cardiac disorders     
ANGINA PECTORIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
CARDIAC FAILURE * 1  1/53 (1.89%)  3 0/33 (0.00%)  0
CARDIAC FAILURE CONGESTIVE * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Palpitations * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PRINZMETAL ANGINA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Congenital, familial and genetic disorders     
CYTOGENETIC ABNORMALITY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Eye disorders     
VISUAL IMPAIRMENT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Gastrointestinal disorders     
COLONIC POLYP * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GASTRIC ULCER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
LOWER GASTROINTESTINAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MELAENA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
General disorders     
OEDEMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PYREXIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Infections and infestations     
PNEUMONIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
PYELONEPHRITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Injury, poisoning and procedural complications     
LACERATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PROSTATE CANCER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Nervous system disorders     
ALTERED STATE OF CONSCIOUSNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CEREBRAL HAEMORRHAGE * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
HEADACHE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK * 1  2/53 (3.77%)  2 1/33 (3.03%)  1
Renal and urinary disorders     
HAEMATURIA * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
INTERSTITIAL LUNG DISEASE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PNEUMOTHORAX * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Vascular disorders     
BASILAR ARTERY THROMBOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CEREBRAL INFARCTION * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
LACUNAR INFARCTION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SPD422: Safety Analysis Set SPD422: Post-marketing Trial Safety Analysis Set
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/53 (100.00%)      13/33 (39.39%)    
Blood and lymphatic system disorders     
ANAEMIA * 1  29/53 (54.72%)  32 0/33 (0.00%)  0
EOSINOPHILIA * 1  4/53 (7.55%)  6 0/33 (0.00%)  0
IRON DEFICIENCY ANAEMIA * 1  6/53 (11.32%)  6 0/33 (0.00%)  0
LEUKOCYTOSIS * 1  1/53 (1.89%)  4 0/33 (0.00%)  0
LEUKOPENIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
LYMPHADENITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
LYMPHADENOPATHY * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
LYMPHOPENIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NEUTROPENIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
RED BLOOD CELL ABNORMALITY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SPLENOMEGALY * 1  2/53 (3.77%)  5 0/33 (0.00%)  0
THROMBOCYTOPENIA * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
Cardiac disorders     
ANGINA PECTORIS * 1  2/53 (3.77%)  5 0/33 (0.00%)  0
AORTIC VALVE INCOMPETENCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ARRHYTHMIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ATRIAL FIBRILLATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
BUNDLE BRANCH BLOCK RIGHT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CARDIAC FAILURE * 1  2/53 (3.77%)  6 0/33 (0.00%)  0
CARDIAC FAILURE CONGESTIVE * 1  3/53 (5.66%)  4 0/33 (0.00%)  0
CARDIOMEGALY * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
CORONARY ARTERY STENOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CYANOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
LONG QT SYNDROME * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MITRAL VALVE INCOMPETENCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PALPITATIONS * 1  21/53 (39.62%)  27 0/33 (0.00%)  0
PERICARDIAL EFFUSION * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
PRINZMETAL ANGINA * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
SINUS TACHYCARDIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
SUPRAVENTRICULAR EXTRASYSTOLES * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TACHYCARDIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
VENTRICULAR EXTRASYSTOLES * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Congenital, familial and genetic disorders     
CYTOGENETIC ABNORMALITY * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Ear and labyrinth disorders     
EUSTACHIAN TUBE DYSFUNCTION * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
TINNITUS * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
VERTIGO * 1  7/53 (13.21%)  10 0/33 (0.00%)  0
Endocrine disorders     
HYPOTHYROIDISM * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Eye disorders     
AGE-RELATED MACULAR DEGENERATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CATARACT * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
CONJUNCTIVAL HAEMORRHAGE * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
CONJUNCTIVITIS * 1  3/53 (5.66%)  4 1/33 (3.03%)  1
DRY EYE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
EYE SWELLING * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
OCULAR HYPERAEMIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PTERYGIUM * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
RETINAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
VISUAL ACUITY REDUCED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
VISUAL IMPAIRMENT * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
ABDOMINAL DISTENSION * 1  4/53 (7.55%)  6 0/33 (0.00%)  0
ABDOMINAL PAIN * 1  3/53 (5.66%)  4 0/33 (0.00%)  0
ABDOMINAL PAIN UPPER * 1  8/53 (15.09%)  10 0/33 (0.00%)  0
ABDOMINAL TENDERNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
APHTHOUS STOMATITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CHEILITIS * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
COLITIS ISCHAEMIC * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
COLONIC POLYP * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
CONSTIPATION * 1  7/53 (13.21%)  7 1/33 (3.03%)  1
DENTAL CARIES * 1  6/53 (11.32%)  7 0/33 (0.00%)  0
DIARRHOEA * 1  19/53 (35.85%)  25 1/33 (3.03%)  1
DIVERTICULUM INTESTINAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DRY MOUTH * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DYSPEPSIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
ENTEROCOLITIS * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
EPIGASTRIC DISCOMFORT * 1  3/53 (5.66%)  4 0/33 (0.00%)  0
FAECAL INCONTINENCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GASTRIC POLYPS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GASTRIC ULCER * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
GASTRITIS * 1  4/53 (7.55%)  8 0/33 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
GINGIVAL BLEEDING * 1  8/53 (15.09%)  10 0/33 (0.00%)  0
GINGIVAL HYPERTROPHY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HAEMATOCHEZIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HAEMORRHOIDS * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
LOWER GASTROINTESTINAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MELAENA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NAUSEA * 1  6/53 (11.32%)  6 0/33 (0.00%)  0
OESOPHAGITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PERIODONTAL DISEASE * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
POLYP COLORECTAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
STOMATITIS * 1  4/53 (7.55%)  4 1/33 (3.03%)  1
VOMITING * 1  5/53 (9.43%)  6 0/33 (0.00%)  0
General disorders     
ASTHENIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CHEST DISCOMFORT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CHEST PAIN * 1  4/53 (7.55%)  6 0/33 (0.00%)  0
CHILLS * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
FACE OEDEMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
FATIGUE * 1  11/53 (20.75%)  14 0/33 (0.00%)  0
GAIT DISTURBANCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MALAISE * 1  5/53 (9.43%)  6 0/33 (0.00%)  0
OEDEMA * 1  5/53 (9.43%)  7 0/33 (0.00%)  0
OEDEMA PERIPHERAL * 1  16/53 (30.19%)  21 0/33 (0.00%)  0
PYREXIA * 1  11/53 (20.75%)  16 0/33 (0.00%)  0
TENDERNESS * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
Hepatobiliary disorders     
CHOLESTASIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GALLBLADDER POLYP * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
HEPATIC FUNCTION ABNORMAL * 1  5/53 (9.43%)  6 0/33 (0.00%)  0
HEPATIC STEATOSIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Infections and infestations     
BRONCHITIS * 1  8/53 (15.09%)  11 1/33 (3.03%)  1
CELLULITIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
CHRONIC SINUSITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CYSTITIS * 1  5/53 (9.43%)  9 1/33 (3.03%)  1
DERMATOPHYTOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DIARRHOEA INFECTIOUS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
EAR INFECTION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ENTERITIS INFECTIOUS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
FOLLICULITIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
GASTROENTERITIS * 1  7/53 (13.21%)  7 0/33 (0.00%)  0
GASTROENTERITIS VIRAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GASTROINTESTINAL INFECTION * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
HAEMOPHILUS INFECTION * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
HERPES ZOSTER * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
INFECTED SKIN ULCER * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
INFLUENZA * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
LIP INFECTION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NASOPHARYNGITIS * 1  22/53 (41.51%)  48 2/33 (6.06%)  4
OESOPHAGEAL CANDIDIASIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ONYCHOMYCOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ORAL HERPES * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
OTITIS EXTERNA * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
OTITIS MEDIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PARONYCHIA * 1  1/53 (1.89%)  4 0/33 (0.00%)  0
PERICORONITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PERIODONTITIS * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
PHARYNGITIS * 1  4/53 (7.55%)  6 1/33 (3.03%)  1
PHARYNGITIS MYCOPLASMAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PNEUMONIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
PYELONEPHRITIS * 1  1/53 (1.89%)  3 0/33 (0.00%)  0
RHINITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TINEA PEDIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION * 1  7/53 (13.21%)  11 0/33 (0.00%)  0
URETHRITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
URINARY TRACT INFECTION * 1  3/53 (5.66%)  3 1/33 (3.03%)  1
VAGINAL INFECTION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Injury, poisoning and procedural complications     
ABDOMEN CRUSHING * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CONTUSION * 1  9/53 (16.98%)  10 0/33 (0.00%)  0
DEAFNESS TRAUMATIC * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
EPICONDYLITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
EXCORIATION * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
FALL * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
FOOT FRACTURE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
FRACTURE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
FROSTBITE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HEAD INJURY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
LACERATION * 1  1/53 (1.89%)  4 0/33 (0.00%)  0
LIGAMENT SPRAIN * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
RIB FRACTURE * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
SUBCUTANEOUS HAEMATOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
THERMAL BURN * 1  1/53 (1.89%)  2 1/33 (3.03%)  1
TOOTH FRACTURE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TRAUMATIC HAEMATOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
WRIST FRACTURE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED * 1  2/53 (3.77%)  5 0/33 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/53 (1.89%)  4 0/33 (0.00%)  0
BLOOD ALKALINE PHOSPHATASE INCREASED * 1  6/53 (11.32%)  7 0/33 (0.00%)  0
BLOOD CREATININE INCREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
BLOOD GLUCOSE INCREASED * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
BLOOD POTASSIUM DECREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
BLOOD PRESSURE INCREASED * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
BLOOD URIC ACID INCREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
BLOOD URINE PRESENT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
C-REACTIVE PROTEIN INCREASED * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
CRYSTAL URINE PRESENT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ELECTROCARDIOGRAM QT PROLONGED * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1  7/53 (13.21%)  9 0/33 (0.00%)  0
GLUCOSE URINE PRESENT * 1  2/53 (3.77%)  5 0/33 (0.00%)  0
HAEMOGLOBIN DECREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HAPTOGLOBIN DECREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HEPATIC ENZYME INCREASED * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
METAMYELOCYTE COUNT INCREASED * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
MYELOCYTE COUNT INCREASED * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
PROSTATIC SPECIFIC ANTIGEN INCREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PROTEIN URINE PRESENT * 1  3/53 (5.66%)  4 0/33 (0.00%)  0
RED BLOOD CELL NUCLEATED MORPHOLOGY PRESENT * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
WEIGHT DECREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
WHITE BLOOD CELL COUNT DECREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
WHITE BLOOD CELL COUNT INCREASED * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Metabolism and nutrition disorders     
DECREASED APPETITE * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
DEHYDRATION * 1  6/53 (11.32%)  7 0/33 (0.00%)  0
FLUID RETENTION * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
GLUCOSE TOLERANCE IMPAIRED * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
HYPERGLYCAEMIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
HYPERKALAEMIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPERLIPIDAEMIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPERURICAEMIA * 1  8/53 (15.09%)  10 0/33 (0.00%)  0
HYPOALBUMINAEMIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPOGLYCAEMIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
METABOLIC DISORDER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA * 1  8/53 (15.09%)  9 0/33 (0.00%)  0
BACK PAIN * 1  8/53 (15.09%)  8 0/33 (0.00%)  0
FLANK PAIN * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
INTERVERTEBRAL DISC PROTRUSION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MUSCLE SPASMS * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
MUSCLE TIGHTNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MUSCULOSKELETAL PAIN * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
MUSCULOSKELETAL STIFFNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MYALGIA * 1  5/53 (9.43%)  5 0/33 (0.00%)  0
OSTEOARTHRITIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
OSTEOPOROSIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
PAIN IN EXTREMITY * 1  10/53 (18.87%)  10 2/33 (6.06%)  2
PERIARTHRITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PERIOSTITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
RHEUMATOID ARTHRITIS * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
SPINAL OSTEOARTHRITIS * 1  2/53 (3.77%)  3 1/33 (3.03%)  1
TENDON CALCIFICATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TENDONITIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACOUSTIC NEUROMA * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
LUNG NEOPLASM * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
MYELOFIBROSIS * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
NEOPLASM * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PROSTATE CANCER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SEBORRHOEIC KERATOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
UTERINE LEIOMYOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Nervous system disorders     
NEURALGIA * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
TRANSIENT ISCHAEMIC ATTACK * 1  2/53 (3.77%)  2 1/33 (3.03%)  1
ALTERED STATE OF CONSCIOUSNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
AMNESIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CEREBRAL HAEMORRHAGE * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
DIZZINESS * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
DIZZINESS POSTURAL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DYSAESTHESIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DYSGEUSIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HEADACHE * 1  26/53 (49.06%)  36 0/33 (0.00%)  0
HYPERAESTHESIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPOAESTHESIA * 1  6/53 (11.32%)  9 0/33 (0.00%)  0
NEUROPATHY PERIPHERAL * 1  2/53 (3.77%)  4 0/33 (0.00%)  0
PALATAL PALSY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PARAESTHESIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
SOMNOLENCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SUBARACHNOID HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SYNCOPE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
TREMOR * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Psychiatric disorders     
ANXIETY * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
INSOMNIA * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
RESTLESSNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Renal and urinary disorders     
CYSTITIS NONINFECTIVE * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
DYSURIA * 1  1/53 (1.89%)  3 0/33 (0.00%)  0
HAEMATURIA * 1  1/53 (1.89%)  6 0/33 (0.00%)  0
HAEMORRHAGE URINARY TRACT * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYDRONEPHROSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYDROURETER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPERTONIC BLADDER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NEPHROLITHIASIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NOCTURIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
POLLAKIURIA * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
PROTEINURIA * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
RENAL IMPAIRMENT * 1  7/53 (13.21%)  8 0/33 (0.00%)  0
RENAL TUBULAR DISORDER * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
URINARY INCONTINENCE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
CERVICAL DYSPLASIA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CYSTOCELE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ERECTILE DYSFUNCTION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
GENITAL HAEMORRHAGE * 1  1/53 (1.89%)  1 1/33 (3.03%)  1
VAGINAL HAEMORRHAGE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ASTHMA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
COUGH * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
DYSPNOEA * 1  8/53 (15.09%)  9 0/33 (0.00%)  0
EPISTAXIS * 1  8/53 (15.09%)  13 1/33 (3.03%)  1
HAEMOPTYSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
INTERSTITIAL LUNG DISEASE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
OROPHARYNGEAL PAIN * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
PLEURAL EFFUSION * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
PNEUMONIA ASPIRATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PNEUMOTHORAX * 1  1/53 (1.89%)  3 0/33 (0.00%)  0
PULMONARY SARCOIDOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
SPUTUM INCREASED * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
UPPER RESPIRATORY TRACT INFLAMMATION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Skin and subcutaneous tissue disorders     
ASTEATOSIS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
CHRONIC PIGMENTED PURPURA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DERMAL CYST * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
DERMATITIS CONTACT * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
DRY SKIN * 1  5/53 (9.43%)  6 0/33 (0.00%)  0
ECZEMA * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
ECZEMA ASTEATOTIC * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
ECZEMA NUMMULAR * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ERYTHEMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HAEMORRHAGE SUBCUTANEOUS * 1  4/53 (7.55%)  4 0/33 (0.00%)  0
SEBORRHOEIC DERMATITIS * 1  2/53 (3.77%)  2 1/33 (3.03%)  1
RASH * 1  7/53 (13.21%)  9 1/33 (3.03%)  1
HEAT RASH * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
INGROWING NAIL * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
NIGHT SWEATS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PIGMENTATION DISORDER * 1  3/53 (5.66%)  3 0/33 (0.00%)  0
PRURITUS * 1  4/53 (7.55%)  5 0/33 (0.00%)  0
PURPURA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
RASH ERYTHEMATOUS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
ROSACEA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
URTICARIA * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
Surgical and medical procedures     
SKIN LESION EXCISION * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
Vascular disorders     
ARTERIOSCLEROSIS * 1  2/53 (3.77%)  2 0/33 (0.00%)  0
BASILAR ARTERY THROMBOSIS * 1  1/53 (1.89%)  2 0/33 (0.00%)  0
CEREBRAL INFARCTION * 1  7/53 (13.21%)  7 0/33 (0.00%)  0
ERYTHROMELALGIA * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
HAEMATOMA * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
HYPERTENSION * 1  14/53 (26.42%)  15 1/33 (3.03%)  1
LACUNAR INFARCTION * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
ORTHOSTATIC HYPOTENSION * 1  2/53 (3.77%)  5 0/33 (0.00%)  0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE * 1  2/53 (3.77%)  3 0/33 (0.00%)  0
PERIPHERAL CIRCULATORY FAILURE * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
PERIPHERAL COLDNESS * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
RAYNAUD'S PHENOMENON * 1  1/53 (1.89%)  1 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire
Phone: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01467661     History of Changes
Other Study ID Numbers: SPD422-309
First Submitted: October 31, 2011
First Posted: November 9, 2011
Results First Submitted: May 2, 2016
Results First Posted: June 8, 2016
Last Update Posted: December 14, 2018