Trial Outcomes & Findings for Agrylin Drug Use-Result Survey (NCT NCT03625895)
NCT ID: NCT03625895
Last Updated: 2023-02-27
Results Overview
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Recruitment status
COMPLETED
Target enrollment
1826 participants
Primary outcome timeframe
From start of study drug administration up to 12 months
Results posted on
2023-02-27
Participant Flow
Participant s took part in the survey at 513 investigative sites in Japan, from 25 November 2014 to 11 March 2021.
Participants with a historical diagnosis of essential thrombocythemia were enrolled. Participants received anagrelide hydrochloride as part of a routine medical care.
Participant milestones
| Measure |
Anagrelide Hydrochloride
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
1826
|
|
Overall Study
COMPLETED
|
1241
|
|
Overall Study
NOT COMPLETED
|
585
|
Reasons for withdrawal
| Measure |
Anagrelide Hydrochloride
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Overall Study
Protocol Violation
|
585
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Anagrelide Hydrochloride
n=1241 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Age, Customized
≤ 17
|
7 Participants
n=1241 Participants
|
|
Age, Customized
18 - 64
|
443 Participants
n=1241 Participants
|
|
Age, Customized
≥ 65
|
790 Participants
n=1241 Participants
|
|
Age, Customized
Unknown
|
1 Participants
n=1241 Participants
|
|
Sex: Female, Male
Female
|
705 Participants
n=1241 Participants
|
|
Sex: Female, Male
Male
|
536 Participants
n=1241 Participants
|
|
Region of Enrollment
Japan
|
1241 participants
n=1241 Participants
|
|
History of Essential Thrombocythemia
|
5.7 years
STANDARD_DEVIATION 6.10 • n=1241 Participants
|
|
Platelet Count at Registration
|
97.7 10^4 platelets/µL
STANDARD_DEVIATION 45.63 • n=1241 Participants
|
|
Janus kinase (JAK)-2 Status
Positive
|
374 Participants
n=1241 Participants
|
|
Janus kinase (JAK)-2 Status
Negative
|
276 Participants
n=1241 Participants
|
|
Janus kinase (JAK)-2 Status
Not Done
|
584 Participants
n=1241 Participants
|
|
Janus kinase (JAK)-2 Status
Unknown
|
7 Participants
n=1241 Participants
|
|
Prior Thrombocythemia Therapy
Had No Prior Thrombocythemia Therapy (Treatment Naïve)
|
242 Participants
n=1241 Participants
|
|
Prior Thrombocythemia Therapy
Had Prior Thrombocythemia Therapy
|
999 Participants
n=1241 Participants
|
|
Pregnancy Test at Baseline
Positive
|
0 Participants
n=705 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Pregnancy Test at Baseline
Negative
|
4 Participants
n=705 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Pregnancy Test at Baseline
Not Done/Unknown
|
701 Participants
n=705 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Medical History/Complication
Had No Medical History/Complication
|
445 Participants
n=1241 Participants
|
|
Medical History/Complication
Had Medical History/Complication
|
796 Participants
n=1241 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 12 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1241 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Adverse Events
|
776 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 12 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1241 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Serious Adverse Event
|
234 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 12 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1241 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Adverse Drug Reactions
|
628 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 12 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1241 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Serious Adverse Drug Reactions
|
100 Participants
|
PRIMARY outcome
Timeframe: From 3 months after the start of study drug administration, up to 12 monthsPopulation: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to \<60 x10\^4 platelet/mcrL beyond 3 months after the start of study drug administration.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=880 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Who Responded in Platelet Count
|
61.02 Percentage of Participants
|
PRIMARY outcome
Timeframe: From 3 months after the start of study drug administration, up to 12 monthsPopulation: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to \<40 x10\^4 platelets/mcrL beyond 3 months after the start of study drug administration.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1039 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With Normalization in Platelet Count
|
28.97 Percentage of Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 12 monthsPopulation: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.
Outcome measures
| Measure |
Anagrelide Hydrochloride
n=1203 Participants
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants With at Least 50% Reduction in Platelet Count
|
38.90 Percentage of Participants
|
Adverse Events
Anagrelide Hydrochloride
Serious events: 234 serious events
Other events: 477 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
Anagrelide Hydrochloride
n=1241 participants at risk
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Blood creatinine increased
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Aortic dissection
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.48%
6/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Pancreatic enzymes increased
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Investigations
Platelet count decreased
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.48%
6/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Brain stem infarction
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.48%
6/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
17/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.40%
5/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Psychiatric disorders
Delirium
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal disorder
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.56%
7/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.40%
5/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
13/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.56%
7/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.32%
4/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Surgical and medical procedures
Dialysis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
4/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
6/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.64%
8/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina unstable
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
6/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Bradycardia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure
|
1.5%
19/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.89%
11/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure high output
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
5/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Right ventricular failure
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Torsade de pointes
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Basedow's disease
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Angle closure glaucoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Asthenia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Condition aggravated
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Death
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Oedema
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Pyrexia
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Cellulitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Fungal infection
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Hepatitis E
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Sepsis
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Septic shock
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Vascular device infection
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Aortic thrombosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.16%
2/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Haematoma
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Hypertension
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Internal haemorrhage
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Polyarteritis nodosa
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Prinzmetal angina
|
0.24%
3/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.08%
1/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Other adverse events
| Measure |
Anagrelide Hydrochloride
n=1241 participants at risk
Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Nervous system disorders
Headache
|
14.5%
180/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Palpitations
|
12.4%
154/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
76/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
67/1241 • From start of study drug administration up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER