Trial Outcomes & Findings for Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI) (NCT NCT03672097)

NCT ID: NCT03672097

Last Updated: 2021-11-12

Results Overview

The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 204 participants
• Primary outcome timeframe: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
• Results posted on: 2021-11-12

Participant Flow

A total of 204 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 10 clinic sites in Taiwan from 01 Nov 2018 to 19 Aug 2020. One patient did not receive study treatment.

Participants with a previous diagnosis of acute coronary syndrome (ACS) who had undergone percutaneous coronary intervention (PCI) and had been previously treated with a maintenance dose of clopidogrel.

Participant milestones

Measure	Prasugrel Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Period 1 STARTED	204
Period 1 COMPLETED	200
Period 1 NOT COMPLETED	4
Period 2 STARTED	200
Period 2 COMPLETED	196
Period 2 NOT COMPLETED	4

Reasons for withdrawal

Measure	Prasugrel Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Period 1 Withdrawal by Subject	2
Period 1 Adverse Event	1
Period 1 Did not receive treatment	1
Period 2 Withdrawal by Subject	3
Period 2 Other	1

Baseline Characteristics

Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)

Baseline characteristics by cohort

Measure	Prasugrel n=203 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants
Age, Categorical >=65 years	73 Participants n=5 Participants
Age, Continuous	60.6 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	203 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Taiwan	203 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

Population: The P2Y12 reaction unit change from baseline was assessed in patients with available data in the Safety Population.

The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented.

Outcome measures

Measure	Prasugrel n=200 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1	-18.2 P2Y12 reaction unit Standard Deviation 48.1

PRIMARY outcome

Timeframe: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Population: Number of participants with major bleeding events was assessed in the Safety Population.

All safety events were assessed in the overall Safety Population, regardless of the study period. The incidence of major bleeding events (defined as non-coronary artery bypass grafting [CABG] thrombolysis in myocardial infarction (TIMI) major) after 28 maintenance dose treatment weeks (optional maximum 12-month P2Y12 inhibitor treatment after ACS participants underwent PCI) are reported. Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days)

Outcome measures

Measure	Prasugrel n=203 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2	4 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

Population: High On-Treatment Platelet Reactivity was assessed in the Safety Population.

High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.

Outcome measures

Measure	Prasugrel n=203 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 Baseline	23 Participants
Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 Week 4	6 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

Population: Platelet inhibition was assessed in participants with available data in the Safety Population.

The mean percentage change in platelet inhibition at the end of the 4-week maintenance dose prasugrel treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose is reported.

Outcome measures

Measure	Prasugrel n=200 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1	7.2 percentage of platelet inhibition Standard Deviation 20.4

SECONDARY outcome

Timeframe: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

Population: Adverse events of special interest were assessed in the Safety Population.

Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.

Outcome measures

Measure	Prasugrel n=203 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Number of Participants With Adverse Events of Special Interest During Period 1 Any minor bleeding AE	1 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any clinically relevant bleeding AE	2 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any MACE, Cardiovascular death	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any MACE, Non-fatal myocardial infarction	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any MACE, Non-fatal stroke	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any MACE, Stent thrombosis	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any MACE, Revascularization	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 1 Any major bleeding adverse events (AE)	0 Participants

SECONDARY outcome

Timeframe: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Population: Adverse events of special interest were assessed in the Safety Population.

All safety events were assessed in the overall Safety Population, regardless of the study period. Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.

Outcome measures

Measure	Prasugrel n=203 Participants Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Number of Participants With Adverse Events of Special Interest During Period 2 Any major bleeding AE	4 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any minor bleeding AE	12 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any clinically relevant bleeding AE	4 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any MACE, Cardiovascular death	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any MACE, Non-fatal myocardial infarction	2 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any MACE, Non-fatal stroke	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any MACE, Stent thrombosis	0 Participants
Number of Participants With Adverse Events of Special Interest During Period 2 Any MACE, Revascularization	0 Participants

Adverse Events

Prasugrel

Serious events: 28 serious events

Other events: 125 other events

Deaths: 1 deaths

Serious adverse events

Measure	Prasugrel n=203 participants at risk Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Angina pectoris	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Acute myocardial infarction	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hepatitis acute	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Diarrhoea	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Duodenal ulcer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure acute	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure congestive	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Chest pain	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Pyrexia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Diverticulitis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Pneumonia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Road traffic accident	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Skin abrasion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Dizziness	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Cerebral haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Tonic convulsion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Haematuria	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Hydronephrosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Blood and lymphatic system disorders Anaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Cholecystitis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hepatic mass	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Vascular disorders Peripheral arterial occlusive disease	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.

Other adverse events

Measure	Prasugrel n=203 participants at risk Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI).
Gastrointestinal disorders Abdominal pain upper	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Diarrhoea	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Abdominal discomfort	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Constipation	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Dental caries	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Abdominal distension	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Anal haemorrhage	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gastric ulcer	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gingival bleeding	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Upper gastrointestional haemorrhage	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Abdominal pain	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Duodenal ulcer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Dyspepsia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Gingival discomfort	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Inguinal hernia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Mouth ulceration	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Nausea	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Oral disorder	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Rectal haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Gastrointestinal disorders Tooth pulp haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Angina pectoris	3.4% 7/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Acute myocardial infarction	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Atrial fibrillation	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure acute	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Cardiac failure congestive	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Palpitations	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Sinus bradycardia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Supraventricular extrasystoles	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Tachycardia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Cardiac disorders Ventricular tachycardia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 5/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Chest pain	3.0% 6/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Chest discomfort	2.5% 5/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Oedema peripheral	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Pyrexia	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Asthenia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
General disorders Non-cardiac chest pain	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Upper respiratory tract infection	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Conjunctivitis	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Influenza	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Body tinea	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Dermatophytosis of nail	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Diverticulitis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Herpes virus infection	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Nasopharyngitis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Periodontitis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Pneumonia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Tinea pedis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Urinary tract infection	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Infections and infestations Wound infection	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Contusion	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Overdose	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Tendon injury	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Fracture	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Rib fracture	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Road traffic accident	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Skin abrasion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Injury, poisoning and procedural complications Wound	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Alanine aminotransferase increased	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Aspartate aminotransferase increased	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Liver function test abnormal	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Blood alkaline phosphatase increased	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Blood bilirubin increased	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Blood glucose increased	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Liver function test increased	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Low density lipoprotein increased	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Investigations Weight increased	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Dizziness	3.0% 6/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Hypoaesthesia	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Poor quality sleep	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Syncope	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Cerebral haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Diabetic neuropathy	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Dizziness postural	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Headache	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Nervous system disorders Tonic convulsion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Myalgia	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Arthritis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Muscle spasms	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Neck pain	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Pain in extremity	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Skin and subcutaneous tissue disorders Ecchymosis	3.4% 7/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Skin and subcutaneous tissue disorders Dermatitis	1.5% 3/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Skin and subcutaneous tissue disorders Rash	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Skin and subcutaneous tissue disorders Pruritus	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Haematuria	2.0% 4/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Chronic kidney disease	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Nocturia	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Acute kidney injury	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Calculus bladder	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Dysuria	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Hydronephrosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Nephritis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Pollakiuria	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Renal failure	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Renal and urinary disorders Renal impairment	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Blood and lymphatic system disorders Anaemia	3.9% 8/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Blood and lymphatic system disorders Thrombocytosis	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Cholecystitis	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hepatitis	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hepatitis acute	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hepatic mass	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Hepatobiliary disorders Hyperbilirubinaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Gout	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Hyperkalaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Hyperlipidaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Hypocalcaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Hypoglycaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Metabolism and nutrition disorders Hypokalaemia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Eye disorders Vision blurred	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Eye disorders Ocular discomfort	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Reproductive system and breast disorders Breast tenderness	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Surgical and medical procedures Tooth extraction	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Surgical and medical procedures Stent placement	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Vascular disorders Haematoma	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Vascular disorders Haemorrhage	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Vascular disorders Peripheral arterial occlusive disease	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Ear and labyrinth disorders Vertigo	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Ear and labyrinth disorders Vestibular disorder	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Psychiatric disorders Insomnia	0.99% 2/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.
Immune system disorders Hypersensitivity	0.49% 1/203 • Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place