Study: NCT02656290

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | ALLERGIC REACTION - MEDICATION RELATED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | ANAPHYLACTIC REACTION
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - ATRIAL FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - TACHYCARDIA -VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD AND LYMPHATIC (INCLUDING ALL BLEEDING COMPLICATIONS) | BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLOOD AND LYMPHATIC (INCLUDING ALL BLEEDING COMPLICATIONS) | BLEEDING - GASTROINTESTINAL UPPER - MAJ
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - MISC | PERICARDIAL EFFUSION - MINOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC | STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+3
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - STENOSIS | STENOSIS - PULMONARY - MODERATE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: CARDIOVASCULAR - MISC | CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+3
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 26 at risk

Adverse event: CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+4
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 26 at risk

Adverse event: CARDIOVASCULAR - STENOSIS | STENOSIS - PULMONARY - MODERATE
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC | MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | NONSPECIFIC, UNKNOWN OR OTHER BODY SYSTEM - OTHER COMPL
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: PULMONARY/RESPIRATORY | ATELECTASIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: PULMONARY/RESPIRATORY | PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk