Trial Outcomes & Findings for Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease (NCT NCT01126437)

NCT ID: NCT01126437

Last Updated: 2014-06-20

Results Overview

Number of patients with all-cause mortality

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 17183 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2014-06-20

Participant Flow

This table summarizes study treatment disposition and reasons for discontinuation of study medication. Deaths that caused discontinuation from trial medications are included in AEs. Lost to follow-up indicates status at time of discontinuation of trial medication. Vital status was ascertained for 99.7% of patients.

Participant milestones

Measure	Tiotropium 2.5 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Overall Study STARTED	5741	5729	5713
Overall Study COMPLETED	4400	4399	4400
Overall Study NOT COMPLETED	1341	1330	1313

Reasons for withdrawal

Measure	Tiotropium 2.5 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Overall Study Not treated	11	18	19
Overall Study Sites with data irregularities/fraud	6	6	7
Overall Study Adverse Event	602	606	635
Overall Study Lack of Efficacy	65	60	59
Overall Study Protocol Violation	64	66	41
Overall Study Lost to Follow-up	52	63	55
Overall Study Withdrawal by Subject	331	335	319
Overall Study Other reason not specified	210	176	178

Baseline Characteristics

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler	Total n=17116 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 9.1 • n=5 Participants	64.9 years STANDARD_DEVIATION 9.1 • n=7 Participants	65.0 years STANDARD_DEVIATION 9.0 • n=5 Participants	65.0 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	1656 Participants n=5 Participants	1571 Participants n=7 Participants	1652 Participants n=5 Participants	4879 Participants n=4 Participants
Sex: Female, Male Male	4068 Participants n=5 Participants	4134 Participants n=7 Participants	4035 Participants n=5 Participants	12237 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated.

Number of patients with all-cause mortality

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5730 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5711 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5694 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to All-Cause Mortality	440 Number of deaths 7.7	423 Number of deaths 7.4	439 Number of deaths 7.7

PRIMARY outcome

Timeframe: Up to 3 years

Population: Treated set (TS, on-treatment only)

Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).

"Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement.

Exacerbations were classified as follows:

Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to First COPD Exacerbation	707 days to event Interval 662.0 to 750.0	756 days to event Interval 692.0 to 816.0	719 days to event Interval 672.0 to 777.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1.

Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=464 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=461 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=445 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)	1.258 Liter Standard Error 0.012	1.285 Liter Standard Error 0.012	1.295 Liter Standard Error 0.012

SECONDARY outcome

Timeframe: Up to 3 years

Population: Treated Set - on treatment only

The number of COPD exacerbations. COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Number of COPD Exacerbations	6565 number of COPD exacerbations	6425 number of COPD exacerbations	6504 number of COPD exacerbations

SECONDARY outcome

Timeframe: Up to 3 years

Population: treated set - on-treatment only

The results presented below are for the patients with hospitalizations due to COPD exacerbations.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to First Hospitalization Associated With COPD Exacerbation	869 Number of patients with event	826 Number of patients with event	811 Number of patients with event

SECONDARY outcome

Timeframe: Up to 3 years

Population: treated set - on treatment only

Total number of hospitalizations associated with COPD exacerbation.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Number of Hospitalizations Associated With COPD Exacerbation	1316 number of hospitalizations	1284 number of hospitalizations	1216 number of hospitalizations

SECONDARY outcome

Timeframe: Up to 3 years

Population: treated set - on treatment only

COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).

Exacerbations classified as follows:

Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.

Results presented below are number of patients with moderate to severe exacerbations.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to First Moderate to Severe COPD Exacerbation	2769 number of patients with event	2694 number of patients with event	2732 number of patients with event

SECONDARY outcome

Timeframe: Up to 3 years

Population: Treated set - on treatment only

Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5724 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to Onset of First Major Adverse Cardiovascular Event (MACE)	224 number of patients with MACE	222 number of patients with MACE	202 number of patients with MACE

SECONDARY outcome

Timeframe: Up to 3 years

Population: TS including vital status follow-up, DAS

The results presented below are number of patients with death from MACE.

Outcome measures

Measure	Tiotropium 2.5 mcg and Placebo n=5730 Participants Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5711 Participants Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5694 Participants Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler
Time to Death From Major Adverse Cardiovascular Event (MACE)	119 Number of deaths from MACE	113 Number of deaths from MACE	101 Number of deaths from MACE

Adverse Events

Tiotropium 2.5 mcg and Placebo

Serious events: 1932 serious events

Other events: 1932 other events

Deaths: 0 deaths

Tiotropium 5 mcg and Placebo

Serious events: 1876 serious events

Other events: 1876 other events

Deaths: 0 deaths

Tiotropium 18 mcg and Placebo

Serious events: 1928 serious events

Other events: 1928 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tiotropium 2.5 mcg and Placebo n=5724 participants at risk Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 participants at risk Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 participants at risk Patients receive one of the active tiotropium arms daily Tiotropium 18 mcg: HandiHaler
General disorders Implant site inflammation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Malaise	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Feeding disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Anaemia	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Febrile neutropenia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Hypercoagulation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Iron deficiency anaemia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Leukocytosis	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Pancytopenia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Pernicious anaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Acute coronary syndrome	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Acute myocardial infarction	0.37% 21/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.37% 21/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Angina pectoris	0.35% 20/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.49% 28/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.39% 22/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Angina unstable	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.33% 19/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Aortic valve disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Aortic valve disease mixed	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Aortic valve incompetence	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Aortic valve stenosis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Arrhythmia	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Arrhythmia supraventricular	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Arteriosclerosis coronary artery	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrial fibrillation	0.72% 41/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.65% 37/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.56% 32/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrial flutter	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrial tachycardia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrioventricular block	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrioventricular block complete	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Atrioventricular block second degree	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Bradycardia	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Bundle branch block left	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Bundle branch block right	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac arrest	0.21% 12/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac asthma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac failure	0.52% 30/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.40% 23/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.42% 24/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac failure acute	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac failure chronic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac failure congestive	0.45% 26/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.39% 22/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.51% 29/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiac valve disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardio-respiratory arrest	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiomegaly	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiomyopathy	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiomyopathy alcoholic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiopulmonary failure	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.19% 11/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cardiovascular disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Congestive cardiomyopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cor pulmonale	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cor pulmonale acute	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Cor pulmonale chronic	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Coronary artery disease	0.31% 18/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.44% 25/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.40% 23/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Coronary artery insufficiency	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Coronary artery occlusion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Coronary artery stenosis	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Diastolic dysfunction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Hypertensive heart disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ischaemic cardiomyopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Left ventricular dysfunction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Left ventricular failure	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Mitral valve incompetence	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Myocardial infarction	0.93% 53/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.79% 45/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.69% 39/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Myocardial ischaemia	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.19% 11/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Palpitations	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Pericardial effusion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Pericarditis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Postinfarction angina	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Prinzmetal angina	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Right ventricular failure	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Sick sinus syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Silent myocardial infarction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Sinus bradycardia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Stress cardiomyopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Tachyarrhythmia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Tachycardia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ventricular arrhythmia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ventricular dysfunction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ventricular extrasystoles	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ventricular fibrillation	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Cardiac disorders Ventricular tachycardia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Congenital, familial and genetic disorders Alpha-1 anti-trypsin deficiency	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Congenital, familial and genetic disorders Congenital absence of bile ducts	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Congenital, familial and genetic disorders Hamartoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Ear and labyrinth disorders Deafness	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Ear and labyrinth disorders Hypoacusis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Ear and labyrinth disorders Vertigo	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Adrenal mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Goitre	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Hyperthyroidism	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Hypothyroidism	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Endocrine disorders Thyroid mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Amaurosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Amaurosis fugax	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Cataract	0.23% 13/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Cataract subcapsular	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Eyelid ptosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Glaucoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Lens dislocation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Macular degeneration	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Open angle glaucoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Retinal detachment	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Retinal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Retinal infarction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Strabismus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Ulcerative keratitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Eye disorders Vitreous haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal adhesions	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal distension	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal hernia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal pain	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Abdominal wall haematoma	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Acute abdomen	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Anal fistula	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Colitis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Colitis ischaemic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Colonic fistula	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Colonic stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Constipation	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Crohn's disease	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Dental caries	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Diarrhoea	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Diverticular perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Diverticulum	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Diverticulum intestinal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenal scarring	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenal stenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenal ulcer	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Duodenogastric reflux	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Dyspepsia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Dysphagia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Enteritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Enterocolitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Enterocutaneous fistula	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Faecaloma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Femoral hernia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Food poisoning	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastric haemorrhage	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastric polyps	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastric ulcer	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastritis	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastritis atrophic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastritis erosive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastritis haemorrhagic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastroduodenitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.19% 11/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrointestinal inflammation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Gastrooesophagitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Haematemesis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Haematochezia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Haemorrhoids	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Hiatus hernia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Ileus	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Ileus paralytic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Inguinal hernia	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.28% 16/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.26% 15/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Inguinal hernia, obstructive	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal mass	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal obstruction	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Intestinal polyp	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Irritable bowel syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Jejunal ulcer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Large intestinal obstruction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Large intestine perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Large intestine polyp	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Lumbar hernia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Malabsorption	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Mechanical ileus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Megacolon	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Melaena	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Mesenteric artery thrombosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Mouth ulceration	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Nausea	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Obstruction gastric	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophageal food impaction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophageal perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophageal stenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophagitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Oesophagitis ulcerative	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatitis	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatitis acute	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatitis chronic	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pancreatolithiasis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Papilla of Vater stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Peptic ulcer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Peptic ulcer perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Proctalgia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Proctocolitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Rectal prolapse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Reflux gastritis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Retching	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Retroperitoneal mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Small intestinal obstruction	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Stomatitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Subileus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Umbilical hernia	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Volvulus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Gastrointestinal disorders Vomiting	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Adverse drug reaction	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Asthenia	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Cardiac death	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Chest discomfort	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Chest pain	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Condition aggravated	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Death	0.49% 28/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.37% 21/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Device dislocation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Device failure	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Device lead damage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Device malfunction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Device occlusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Drowning	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Drug withdrawal syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Effusion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Exercise tolerance decreased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Fibrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders General physical health deterioration	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Hernia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Hernia obstructive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Hyperthermia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Impaired healing	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Implant site calcification	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Multi-organ disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Multi-organ failure	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Necrosis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Non-cardiac chest pain	0.33% 19/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.40% 23/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.39% 22/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Oedema	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Oedema peripheral	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Polyp	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Pyrexia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Spinal pain	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Sudden cardiac death	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Sudden death	0.47% 27/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.32% 18/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Systemic inflammatory response syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Ulcer haemorrhage	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
General disorders Vessel puncture site haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Bile duct obstruction	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Bile duct stone	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Biliary colic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Biliary cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Biliary dyskinesia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Cholangitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Cholecystitis	0.19% 11/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Cholecystitis acute	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Cholecystitis chronic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Cholelithiasis	0.21% 12/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Gallbladder perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatic cirrhosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatic congestion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatic failure	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatic ischaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatic mass	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatitis acute	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Liver disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Amyloidosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Anaphylactic reaction	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Anaphylactic shock	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Autoimmune disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Drug hypersensitivity	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Food allergy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Immune system disorders Hypersensitivity	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abdominal abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abdominal sepsis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abscess intestinal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abscess limb	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Abscess neck	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Acinetobacter infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Acute sinusitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Amoebic dysentery	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Anal abscess	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Anal infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Appendiceal abscess	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Appendicitis	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Appendicitis perforated	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Arthritis bacterial	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Arthritis infective	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Atypical mycobacterial infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Atypical pneumonia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bacteraemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bacterial infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bacterial toxaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bronchitis	0.28% 16/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.19% 11/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bronchitis bacterial	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bronchopneumonia	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Bursitis infective	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Campylobacter infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Cellulitis	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Cholecystitis infective	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Chronic hepatitis C	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Chronic sinusitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Clostridium colitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Clostridium difficile colitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Clostridium difficile infection	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Colon gangrene	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Cystitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Dengue fever	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Device related infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Diarrhoea infectious	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Diverticulitis	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Ear infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Eczema infected	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Empyema	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Endocarditis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Endophthalmitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Enterobacter pneumonia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Enterococcal sepsis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Enterocolitis infectious	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Enterocolitis viral	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Erysipelas	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Eye infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Febrile infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Fungal infection	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gallbladder empyema	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gangrene	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastritis viral	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis	0.19% 11/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis bacterial	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis clostridial	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis norovirus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis salmonella	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Gastroenteritis viral	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Groin abscess	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Groin infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations H1N1 influenza	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Haematoma infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Helicobacter gastritis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Helicobacter infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Hepatic cyst infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Hepatitis B	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Hepatitis C	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Hepatitis viral	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Herpes virus infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Herpes zoster	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Herpes zoster ophthalmic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Herpes zoster oticus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Implant site infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Incision site infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Infectious pleural effusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.28% 16/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Influenza	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Intervertebral discitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Kidney infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Klebsiella infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Klebsiella sepsis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Labyrinthitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Laryngitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Liver abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Lobar pneumonia	0.28% 16/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.26% 15/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Localised infection	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Lower respiratory tract infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Lung abscess	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Lung infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Lyme disease	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Mastitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Measles	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Neutropenic sepsis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Nosocomial infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Oesophageal candidiasis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Orchitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Osteomyelitis	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Otitis media	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pelvic abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Perineal abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Peritonitis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pertussis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pharyngitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumocystis jiroveci infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia	5.9% 339/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	6.0% 344/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	6.0% 340/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia bacterial	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia influenzal	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia legionella	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia necrotising	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia pneumococcal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia pseudomonas aeruginosa	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia staphylococcal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia streptococcal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pneumonia viral	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Postoperative abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Postoperative wound infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pseudomembranous colitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pseudomonas bronchitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Psoas abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pulmonary tuberculoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pulmonary tuberculosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Purulence	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pyelonephritis	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pyelonephritis acute	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pyelonephritis chronic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pyoderma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Pyonephrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Rectal abscess	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Respiratory tract infection	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Scrotal abscess	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Sepsis	0.31% 18/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.39% 22/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.28% 16/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Sepsis syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Septic shock	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Serratia infection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Sialoadenitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Sinusitis	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Skin infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Soft tissue infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Staphylococcal infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Staphylococcal sepsis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Streptococcal sepsis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Subcutaneous abscess	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Tracheobronchitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Tuberculosis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Upper respiratory tract infection	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Urethral abscess	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Urinary tract infection	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.39% 22/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Urinary tract infection bacterial	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Urosepsis	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Vestibular neuronitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Viral diarrhoea	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Viral infection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Infections and infestations Wound infection	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Accident	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Alcohol poisoning	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Anaemia postoperative	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Animal bite	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Ankle fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Arterial restenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Arthropod sting	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Bone contusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Burns second degree	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Chemical poisoning	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Clavicle fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Comminuted fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Concussion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Contusion	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Craniocerebral injury	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Excoriation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Face injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Fall	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.33% 19/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Femoral neck fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Femur fracture	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Fibula fracture	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Foot fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Foreign body	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Hand fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Head injury	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Hip fracture	0.19% 11/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.19% 11/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Humerus fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Incisional hernia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Injury corneal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Joint dislocation	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Joint injury	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Laceration	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Limb injury	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Open fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Overdose	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Patella fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Pelvic fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Pneumoconiosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Pneumonitis chemical	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post procedural complication	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post procedural contusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Postoperative ileus	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Procedural pain	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Radius fracture	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Rib fracture	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Road traffic accident	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Scar	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Skin graft failure	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Skin injury	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Skull fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Spinal compression fracture	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Spinal fracture	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Splinter	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Tendon rupture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Tibia fracture	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Toxicity to various agents	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Traumatic lung injury	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Upper limb fracture	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Urethral injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Vascular graft occlusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Wound	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Injury, poisoning and procedural complications Wrist fracture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Angiogram	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Arteriogram coronary normal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Arthroscopy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Biopsy lung	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Biopsy vocal cord normal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Blood creatinine increased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Blood pressure increased	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Catheterisation cardiac	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Chest X-ray abnormal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Fibrin D dimer increased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Full blood count decreased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations International normalised ratio abnormal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations International normalised ratio increased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Investigation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Laparoscopy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Oxygen saturation decreased	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Prostatic specific antigen increased	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Troponin I increased	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Investigations Weight decreased	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Dehydration	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Diabetes mellitus	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Diabetes with hyperosmolarity	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Gout	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hyperglycaemia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hypoglycaemia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hypokalaemia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hyponatraemia	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hypophagia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Hypovolaemia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Lactic acidosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Malnutrition	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Obesity	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Arthritis	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Back pain	0.19% 11/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Bone infarction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Bursa disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Chondritis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Fracture malunion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Joint swelling	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Knee deformity	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Mixed connective tissue disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Muscular weakness	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Myalgia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Myopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Neck pain	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.40% 23/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Osteoporosis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Pain in extremity	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Periarthritis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acral lentiginous melanoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Migraine	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell unclassifiable lymphoma low grade	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.30% 17/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.46% 26/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.26% 15/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of urethra	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder adenocarcinoma stage unspecified	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.23% 13/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Motor dysfunction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage 0, with cancer in situ	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.23% 13/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer stage IV	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage I	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.91% 52/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	1.1% 60/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.84% 48/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage IV	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant splenic neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to muscle	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to retroperitoneum	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spleen	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal cavity cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer stage II	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal neoplasm benign	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage I	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage II	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.30% 17/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.30% 17/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Signet-ring cell carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Myelopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic marginal zone lymphoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.33% 19/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary tract carcinoma in situ	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vascular neoplasm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vocal cord neoplasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Altered state of consciousness	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Aphasia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Brain hypoxia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Brain injury	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Brain oedema	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Brain stem infarction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Carotid artery stenosis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cauda equina syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebellar ataxia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral arteriosclerosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral artery embolism	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral haemorrhage	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral infarction	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral ischaemia	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebral thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebrosclerosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebrovascular accident	0.61% 35/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.67% 38/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.62% 35/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Cervical myelopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Coma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Complicated migraine	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Convulsion	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Dementia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Dementia Alzheimer's type	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Diabetic neuropathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Dizziness	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Dysarthria	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Embolic stroke	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Encephalitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Encephalopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Epilepsy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Facial spasm	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Grand mal convulsion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Guillain-Barre syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Haemorrhage intracranial	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Haemorrhagic stroke	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Headache	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hemiplegia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hepatic encephalopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hydrocephalus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hypertensive encephalopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hypertonia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hypoaesthesia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hypoglycaemic coma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Intercostal neuralgia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Intracranial aneurysm	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Intracranial haematoma	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Ischaemic stroke	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Lacunar infarction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Loss of consciousness	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Metabolic encephalopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Myoclonus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Nervous system disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Paraesthesia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Parkinson's disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Peripheral nerve lesion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Polyneuropathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Post herpetic neuralgia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Presyncope	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Quadriplegia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Radial nerve palsy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Sciatica	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Spinal cord compression	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Spinal cord infarction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Spinal cord ischaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Status epilepticus	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Subarachnoid haemorrhage	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Syncope	0.24% 14/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.30% 17/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.26% 15/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Tension headache	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Tongue biting	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Tonic convulsion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Toxic encephalopathy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Transient ischaemic attack	0.31% 18/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.40% 23/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Tremor	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Trigeminal neuralgia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Ulnar tunnel syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders VIIth nerve paralysis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Vascular dementia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Vascular encephalopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Nervous system disorders Vocal cord paralysis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Alcohol abuse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Alcoholic psychosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Alcoholism	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Anxiety	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Anxiety disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Completed suicide	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Confusional state	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Delirium	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Depressed mood	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Depression	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Disorientation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Drug abuse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Hallucination	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Major depression	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Mania	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Mental disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Mental disorder due to a general medical condition	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Mental status changes	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Psychotic disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Stress	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Substance abuse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Psychiatric disorders Suicide attempt	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Acute prerenal failure	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Azotaemia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Bladder cyst	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Bladder perforation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Bladder prolapse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Calculus bladder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Calculus urethral	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Calculus urinary	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Cystitis haemorrhagic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Dysuria	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Glomerulonephritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Haematuria	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Hydronephrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Ketonuria	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Nephritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Nephrolithiasis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Nephropathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Obstructive uropathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Oliguria	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Postrenal failure	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal artery stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal colic	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal failure	0.16% 9/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal failure acute	0.30% 17/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.42% 24/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal failure chronic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal impairment	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Renal infarct	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urethral stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urinary incontinence	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urinary retention	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Acquired phimosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.25% 14/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Breast mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Cervical dysplasia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Cystocele	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Epididymitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Ovarian mass	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Pelvic pain	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Prostatic dysplasia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Prostatic obstruction	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Prostatitis	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Rectocele	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Spermatic cord inflammation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.52% 30/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.56% 32/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.49% 28/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.12% 7/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Bullous lung disease	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	15.6% 895/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	15.2% 868/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	15.0% 851/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.42% 24/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.30% 17/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.37% 21/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Epiglottic cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.17% 10/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.23% 13/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Laryngeal cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Laryngeal disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Laryngeal leukoplakia	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Lung cyst	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pharyngeal polyp	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleural calcification	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.10% 6/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleural fistula	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.44% 25/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.44% 25/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.37% 21/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary cavitation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.49% 28/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.49% 28/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.42% 24/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Pulmonary venous thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.73% 42/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.70% 40/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.62% 35/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Vocal cord cyst	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Respiratory, thoracic and mediastinal disorders Vocal cord thickening	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Angioedema	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Blister	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Dermatitis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Eczema	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Skin discolouration	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Skin disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Skin ulcer	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Social circumstances Abstains from alcohol	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Social circumstances Cardiac assistance device user	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Angioplasty	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Aortic valve repair	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Aortic valve replacement	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Appendicectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Arterial repair	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Arterial stent insertion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Bladder neoplasm surgery	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Bladder operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Bone graft	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Bone operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cardiac ablation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cardiac pacemaker insertion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cardiac pacemaker removal	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cardiac pacemaker replacement	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Central venous catheterisation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cholecystectomy	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Cholecystostomy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Colon operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Colostomy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Coronary arterial stent insertion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Coronary artery bypass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Coronary endarterectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Coronary revascularisation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Dental implantation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Ear operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Elective surgery	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Endobronchial valve implantation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Frontal sinus operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Gallbladder operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Gastroenterostomy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Haemorrhoid operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Heart valve operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Heart valve replacement	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Hip arthroplasty	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Hip surgery	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Hospitalisation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Hysterectomy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Inguinal hernia repair	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Intervertebral disc operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Knee arthroplasty	0.05% 3/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Large intestine anastomosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Leg amputation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Limb operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Lung transplant	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Lung volume reduction surgery	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Mechanical ventilation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Medical device change	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Medical device removal	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Nasal septal operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Obesity surgery	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Partial lung resection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Peripheral artery bypass	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Polypectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Prophylaxis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Prostatectomy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Prostatic operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Prosthesis implantation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Pulmonary valve replacement	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Rehabilitation therapy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Respiratory therapy	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Rotator cuff repair	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Salpingo-oophorectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Shoulder arthroplasty	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Shoulder operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Skin operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Spinal laminectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Spinal operation	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Stem cell transplant	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Stent placement	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Surgery	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Thyroidectomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Transurethral prostatectomy	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Urethral operation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Urethrotomy	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Vaginoplasty	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Vascular graft	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Surgical and medical procedures Vascular stent insertion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Accelerated hypertension	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aneurysm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aneurysm ruptured	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic aneurysm	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.26% 15/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic aneurysm rupture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic dissection	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic occlusion	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic rupture	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Aortic stenosis	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arterial disorder	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arterial haemorrhage	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arterial occlusive disease	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arterial stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arterial thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arteriosclerosis	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Arteritis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Bleeding varicose vein	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Circulatory collapse	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Deep vein thrombosis	0.09% 5/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.19% 11/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Embolism	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Extremity necrosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Femoral artery occlusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Haematoma	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Haemorrhage	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Hypertension	0.14% 8/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.21% 12/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Hypertensive crisis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Hypotension	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.11% 6/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.16% 9/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Hypovolaemic shock	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Iliac artery occlusion	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Intermittent claudication	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Jugular vein thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Leriche syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Lymphoedema	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.07% 4/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Orthostatic hypotension	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral arterial occlusive disease	0.12% 7/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.14% 8/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.18% 10/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral artery aneurysm	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral artery stenosis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral artery thrombosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral ischaemia	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.09% 5/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Peripheral vascular disorder	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Post thrombotic syndrome	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Shock	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Shock haemorrhagic	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Steal syndrome	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Subclavian artery stenosis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Subclavian vein thrombosis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Thrombophlebitis	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Thrombosis	0.07% 4/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.05% 3/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Varicose vein	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Vascular occlusion	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Vasculitis	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Vasodilatation	0.00% 0/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Venous insufficiency	0.02% 1/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.00% 0/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Vascular disorders Venous thrombosis limb	0.03% 2/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.02% 1/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	0.04% 2/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.

Other adverse events

Measure	Tiotropium 2.5 mcg and Placebo n=5724 participants at risk Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day	Tiotropium 5 mcg and Placebo n=5705 participants at risk Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)	Tiotropium 18 mcg and Placebo n=5687 participants at risk Patients receive one of the active tiotropium arms daily Tiotropium 18 mcg: HandiHaler
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	33.8% 1932/5724 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	32.9% 1876/5705 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.	33.9% 1928/5687 • From the first drug intake up to 30 days after administration Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER