Group A

all-cause mortality Non-Systematic Assessment 0.0 idm711497520 11 7 20 idm711485744 16 8 22 idm711487920 13 7 18 Non-Systematic Assessment Abdominal distension MedDRA 22.0 Abdominal distension idm711497520 9 4 20 idm711485744 14 4 22 idm711487920 4 3 18 Non-Systematic Assessment Abdominal infection MedDRA 22.0 Abdominal infection idm711497520 10 4 20 idm711485744 11 3 22 idm711487920 11 9 18 Non-Systematic Assessment Abdominal soft tissue necrosis MedDRA 22.0 Abdominal soft tissue necrosis idm711497520 17 7 20 idm711485744 11 8 22 idm711487920 18 8 18 Non-Systematic Assessment Abducens nerve disorder MedDRA 22.0 Abducens nerve disorder idm711497520 14 6 20 idm711485744 8 5 22 idm711487920 18 11 18 Non-Systematic Assessment Acidosis MedDRA 22.0 Acidosis idm711497520 8 6 20 idm711485744 14 6 22 idm711487920 7 2 18 Non-Systematic Assessment Activated partial thromboplastin time prolonged MedDRA 22.0 Activated partial thromboplastin time prolonged idm711497520 12 4 20 idm711485744 15 11 22 idm711487920 6 3 18 Non-Systematic Assessment Acute coronary syndrome MedDRA 22.0 Acute coronary syndrome idm711497520 7 2 20 idm711485744 21 11 22 idm711487920 11 5 18 Non-Systematic Assessment Acute kidney injury MedDRA 22.0 Acute kidney injury idm711497520 18 10 20 idm711485744 11 5 22 idm711487920 4 4 18 Non-Systematic Assessment Adrenal insufficiency MedDRA 22.0 Adrenal insufficiency idm711497520 7 4 20 idm711485744 6 3 22 idm711487920 14 8 18 Non-Systematic Assessment Adult respiratory distress syndrome MedDRA 22.0 Adult respiratory distress syndrome idm711497520 5 5 20 idm711485744 7 4 22 idm711487920 8 7 18 Non-Systematic Assessment Agitation MedDRA 22.0 Agitation idm711497520 5 4 20 idm711485744 17 9 22 idm711487920 8 3 18 Non-Systematic Assessment Allergic reaction MedDRA 22.0 Allergic reaction idm711497520 5 4 20 idm711485744 11 5 22 idm711487920 15 5 18 Non-Systematic Assessment Alopecia MedDRA 22.0 Alopecia idm711497520 10 3 20 idm711485744 14 6 22 idm711487920 11 5 18 Non-Systematic Assessment Anemia MedDRA 22.0 Anemia idm711497520 9 5 20 idm711485744 14 4 22 idm711487920 17 8 18 Non-Systematic Assessment Ankle fracture MedDRA 22.0 Ankle fracture idm711497520 16 8 20 idm711485744 15 6 22 idm711487920 11 6 18 Non-Systematic Assessment Azoospermia MedDRA 22.0 Azoospermia idm711497520 7 4 20 idm711485744 16 8 22 idm711487920 9 3 18 Non-Systematic Assessment Bile duct stenosis MedDRA 22.0 Bile duct stenosis idm711497520 7 2 20 idm711485744 9 6 22 idm711487920 16 8 18 Non-Systematic Assessment Blurred vision MedDRA 22.0 Blurred vision idm711497520 8 2 20 idm711485744 5 5 22 idm711487920 8 7 18 Non-Systematic Assessment Capillary leak syndrome MedDRA 22.0 Capillary leak syndrome idm711497520 6 3 20 idm711485744 8 5 22 idm711487920 15 10 18 Non-Systematic Assessment Chills MedDRA 22.0 Chills idm711497520 4 2 20 idm711485744 11 6 22 idm711487920 7 7 18 Non-Systematic Assessment Congenital, familial and genetic disorders - Other, specify MedDRA 22.0 Congenital, familial and genetic disorders - Other, specify idm711497520 18 8 20 idm711485744 16 7 22 idm711487920 8 5 18 Non-Systematic Assessment Ear pain MedDRA 22.0 Ear pain idm711497520 7 4 20 idm711485744 22 14 22 idm711487920 7 6 18 Non-Systematic Assessment Fetal death MedDRA 22.0 Fetal death idm711497520 5 4 20 idm711485744 13 4 22 idm711487920 14 5 18 Non-Systematic Assessment Leukemia secondary to oncology chemotherapy MedDRA 22.0 Leukemia secondary to oncology chemotherapy idm711497520 14 8 20 idm711485744 7 7 22 idm711487920 3 1 18 Non-Systematic Assessment Menopause MedDRA 22.0 Menopause idm711497520 15 6 20 idm711485744 10 4 22 idm711487920 14 4 18 Non-Systematic Assessment Surgical and medical procedures - Other, specify MedDRA 22.0 Surgical and medical procedures - Other, specify Group A 3 10 10 20 20 20 Group A Group B 6 14 13 22 22 22 Group B Group C 2 11 9 18 18 18 Group C idm711497520 8 7 20 idm711485744 4 3 22 idm711487920 8 2 18 Non-Systematic Assessment Abdominal distension MedDRA 22.0 Abdominal distension idm711497520 7 3 20 idm711485744 8 5 22 idm711487920 10 4 18 Non-Systematic Assessment Abdominal infection MedDRA 22.0 Abdominal infection idm711497520 12 5 20 idm711485744 10 4 22 idm711487920 9 6 18 Non-Systematic Assessment Abdominal soft tissue necrosis MedDRA 22.0 Abdominal soft tissue necrosis idm711497520 8 5 20 idm711485744 8 6 22 idm711487920 7 3 18 Non-Systematic Assessment Abducens nerve disorder MedDRA 22.0 Abducens nerve disorder idm711497520 10 8 20 idm711485744 15 5 22 idm711487920 9 2 18 Non-Systematic Assessment Acidosis MedDRA 22.0 Acidosis idm711497520 8 4 20 idm711485744 11 6 22 idm711487920 9 5 18 Non-Systematic Assessment Activated partial thromboplastin time prolonged MedDRA 22.0 Activated partial thromboplastin time prolonged idm711497520 4 3 20 idm711485744 9 4 22 idm711487920 15 9 18 Non-Systematic Assessment Acute coronary syndrome MedDRA 22.0 Acute coronary syndrome idm711497520 5 4 20 idm711485744 9 5 22 idm711487920 0 0 18 Non-Systematic Assessment Acute kidney injury MedDRA 22.0 Acute kidney injury idm711497520 12 5 20 idm711485744 17 12 22 idm711487920 8 3 18 Non-Systematic Assessment Adrenal insufficiency MedDRA 22.0 Adrenal insufficiency idm711497520 17 7 20 idm711485744 22 12 22 idm711487920 12 5 18 Non-Systematic Assessment Adult respiratory distress syndrome MedDRA 22.0 Adult respiratory distress syndrome idm711497520 8 6 20 idm711485744 15 10 22 idm711487920 12 2 18 Non-Systematic Assessment Agitation MedDRA 22.0 Agitation idm711497520 10 7 20 idm711485744 13 8 22 idm711487920 11 7 18 Non-Systematic Assessment Allergic reaction MedDRA 22.0 Allergic reaction idm711497520 6 3 20 idm711485744 10 8 22 idm711487920 3 2 18 Non-Systematic Assessment Alopecia MedDRA 22.0 Alopecia idm711497520 6 6 20 idm711485744 16 7 22 idm711487920 13 3 18 Non-Systematic Assessment Anemia MedDRA 22.0 Anemia idm711497520 6 5 20 idm711485744 9 6 22 idm711487920 14 7 18 Non-Systematic Assessment Ankle fracture MedDRA 22.0 Ankle fracture idm711497520 11 5 20 idm711485744 5 3 22 idm711487920 9 4 18 Non-Systematic Assessment Azoospermia MedDRA 22.0 Azoospermia idm711497520 5 5 20 idm711485744 16 9 22 idm711487920 6 1 18 Non-Systematic Assessment Bile duct stenosis MedDRA 22.0 Bile duct stenosis idm711497520 16 6 20 idm711485744 6 3 22 idm711487920 7 4 18 Non-Systematic Assessment Blurred vision MedDRA 22.0 Blurred vision idm711497520 12 4 20 idm711485744 11 6 22 idm711487920 16 9 18 Non-Systematic Assessment Capillary leak syndrome MedDRA 22.0 Capillary leak syndrome idm711497520 20 10 20 idm711485744 17 7 22 idm711487920 14 6 18 Non-Systematic Assessment Chills MedDRA 22.0 Chills idm711497520 5 5 20 idm711485744 11 4 22 idm711487920 14 9 18 Non-Systematic Assessment Congenital, familial and genetic disorders - Other, specify MedDRA 22.0 Congenital, familial and genetic disorders - Other, specify idm711497520 9 2 20 idm711485744 9 6 22 idm711487920 10 4 18 Non-Systematic Assessment Ear pain MedDRA 22.0 Ear pain idm711497520 7 3 20 idm711485744 14 5 22 idm711487920 8 4 18 Non-Systematic Assessment Fetal death MedDRA 22.0 Fetal death idm711497520 8 5 20 idm711485744 6 4 22 idm711487920 12 8 18 Non-Systematic Assessment Leukemia secondary to oncology chemotherapy MedDRA 22.0 Leukemia secondary to oncology chemotherapy idm711497520 12 8 20 idm711485744 12 6 22 idm711487920 6 6 18 Non-Systematic Assessment Menopause MedDRA 22.0 Menopause idm711497520 5 5 20 idm711485744 16 9 22 idm711487920 7 3 18 Non-Systematic Assessment Surgical and medical procedures - Other, specify MedDRA 22.0 Surgical and medical procedures - Other, specify MedDRA 22.0 Timeframe for AE