Trial Outcomes & Findings for THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death (NCT NCT03354429)
NCT ID: NCT03354429
Last Updated: 2020-12-22
Results Overview
Participants with subsequent stroke or death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
11016 participants
Primary outcome timeframe
From randomisation (day 1) to visit 3 (day 30-34)
Results posted on
2020-12-22
Participant Flow
414 study sites in 28 countries enrolled patients. The first patient was enrolled on 22 January 2018. The last patient visit took place on 13 December 2019.
11073 patients screened; 11016 patients randomised. 57 patients who were not randomised (patient did not meet inclusion/exclusion criteria n=52, patient decision n=5).
Participant milestones
| Measure |
TICAGRELOR
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Overall Study
STARTED
|
5523
|
5493
|
|
Overall Study
COMPLETED
|
5514
|
5486
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
TICAGRELOR
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death
Baseline characteristics by cohort
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
Total
n=11016 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2108 Participants
n=5 Participants
|
2171 Participants
n=7 Participants
|
4279 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3415 Participants
n=5 Participants
|
3322 Participants
n=7 Participants
|
6737 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2973 Participants
n=5 Participants
|
2948 Participants
n=7 Participants
|
5921 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2353 Participants
n=5 Participants
|
2339 Participants
n=7 Participants
|
4692 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
173 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Participants with subsequent stroke or death
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Composite of Subsequent Stroke or Death
|
303 Participants
|
362 Participants
|
SECONDARY outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Number of participants with ischaemic stroke
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Ischaemic Stroke
|
276 Participants
|
345 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (day 30-34)Population: Full analysis set including all randomised patients. Patients with missing mRS score or missing covariates, NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no), were excluded
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Outcome measures
| Measure |
TICAGRELOR
n=5386 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5333 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
|
1282 Participants
|
1284 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe
|
28 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Participants with ICH or fatal bleeding event
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
ICH or Fatal Bleeding Event
|
22 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Moderate/Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention. GUSTO Moderate bleeding is a bleeding requiring transfusion of whole blood or packed red blood cells without haemodynamic compromise
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe
|
36 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)Population: Full analysis set including all randomised patients
Participants with premature permanent discontinuation of IP due to bleeding
Outcome measures
| Measure |
TICAGRELOR
n=5523 Participants
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
PLACEBO
n=5493 Participants
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Premature Permanent Discontinuation of IP Due to Bleeding
|
152 Participants
|
32 Participants
|
Adverse Events
Ticagrelor
Serious events: 571 serious events
Other events: 0 other events
Deaths: 40 deaths
Placebo
Serious events: 609 serious events
Other events: 0 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Ticagrelor
n=5523 participants at risk
Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30
|
Placebo
n=5493 participants at risk
Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30
|
|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Acute coronary syndrome
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Acute left ventricular failure
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.09%
5/5493 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Angina unstable
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
18/5523 • Number of events 18 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.27%
15/5493 • Number of events 17 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Atrial thrombosis
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Bradycardia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac arrest
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac asthma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Coronary artery disease
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Intracardiac thrombus
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Mitral valve disease
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Mitral valve incompetence
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Myocardial infarction
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Sinoatrial block
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Sinus node dysfunction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Cardiac disorders
Ventricular tachycardia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.07%
4/5493 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Congenital, familial and genetic disorders
Vascular malformation
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Eye disorders
Diabetic retinopathy
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Eye disorders
Idiopathic orbital inflammation
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Eye disorders
Visual impairment
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Gastric disorder
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
6/5523 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.11%
6/5493 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Melaena
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.09%
5/5523 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Chest discomfort
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Chest pain
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Death
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.07%
4/5493 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Device related thrombosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
General physical health deterioration
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Necrosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Non-cardiac chest pain
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Pyrexia
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
General disorders
Sudden cardiac death
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Anal abscess
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Appendicitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Brain abscess
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Cellulitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Endocarditis
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Escherichia sepsis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Infectious pleural effusion
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Neurosyphilis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Peritonitis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Pneumonia
|
0.45%
25/5523 • Number of events 25 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.51%
28/5493 • Number of events 29 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Pyelonephritis chronic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Sepsis
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.09%
5/5493 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Septic shock
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Tonsillitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Tuberculosis
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Urinary tract infection
|
0.11%
6/5523 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.13%
7/5493 • Number of events 7 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Urosepsis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Viral infection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Infections and infestations
Wound infection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Investigations
Blood glucose increased
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Investigations
International normalised ratio increased
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Investigations
Occult blood positive
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Gout
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Focal nodular hyperplasia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mediastinal neoplasm
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Balance disorder
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Brain oedema
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Brain stem stroke
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Carotid artery stenosis
|
0.14%
8/5523 • Number of events 8 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.13%
7/5493 • Number of events 7 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Central pain syndrome
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral infarction
|
0.11%
6/5523 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.15%
8/5493 • Number of events 8 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
6/5523 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.13%
7/5493 • Number of events 7 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Dizziness
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Epilepsy
|
0.09%
5/5523 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.13%
7/5523 • Number of events 7 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.14%
8/5523 • Number of events 8 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.11%
6/5493 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Headache
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Intracranial aneurysm
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.11%
6/5493 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Ischaemic stroke
|
4.6%
254/5523 • Number of events 258 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
5.9%
324/5493 • Number of events 330 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Migraine
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Paresis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Partial seizures
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Post stroke seizure
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Seizure
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Status epilepticus
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Stroke in evolution
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Syncope
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Tension headache
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Thalamic infarction
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Transient ischaemic attack
|
0.22%
12/5523 • Number of events 12 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.55%
30/5493 • Number of events 31 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Vascular dementia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Product Issues
Device dislocation
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Confusional state
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Delirium
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Hallucination, visual
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Organic brain syndrome
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Panic disorder
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Psychotic disorder
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Sleep disorder
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Acute kidney injury
|
0.07%
4/5523 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
End stage renal disease
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Haematuria
|
0.14%
8/5523 • Number of events 8 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Renal failure
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.05%
3/5493 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Renal injury
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.04%
2/5523 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
6/5523 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
9/5523 • Number of events 9 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.09%
5/5493 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Aortic dissection
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Aortic intramural haematoma
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Arterial stenosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Arteritis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Haematoma
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Hypertension
|
0.09%
5/5523 • Number of events 5 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.09%
5/5493 • Number of events 6 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
3/5523 • Number of events 3 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.07%
4/5493 • Number of events 4 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Hypertensive urgency
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Hypotension
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.04%
2/5493 • Number of events 2 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Peripheral ischaemia
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/5523 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.02%
1/5493 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Vasculitis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
|
Vascular disorders
Vena cava thrombosis
|
0.02%
1/5523 • Number of events 1 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
0.00%
0/5493 • From randomisation (day 1) to visit 3 (day 30-34)
Only serious adverse events (SAEs) and premature permanent discontinuations of study drug due to AEs (DAEs) were to be collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60