Basic HTML Version

|  | Table of Contents |  | View Full Version

Page 59 - Abbott
P. 59

    Table 13.  Serious Adverse Events Over Part 1 and Part 2

                                                    Part 1                                      Part 2
                                                    Treatment      Control       All Patients   All Patients
                                                    (270)          (280)         (550)          (347)
                                                    Subjects  Events   Subjects  Events   Subjects   Events  Subjects  Events
                    Chest pain (non-cardiac)           2      2       4      7       6      9      0      0
                    Fever                              1      1       3      3       4      4      2      2
                    General malaise                    3      3       0      0       3      3      1      1
                    Death                              1      1       1      1       2      2      7      7
                    Pain                               2      2       0      0       2      2      0      0
                    Sudden cardiac death               1      1       1      1       2      2      1      1
                    Anasarca                           0      0       1      1       1      1      0      0
                    Central line complication          1      2       0      0       1      2      0      0
                    Chest discomfort                   0      0       1      1       1      1      0      0
                    Chest pain aggravated              0      0       1      1       1      1      0      0
                    Chronic fatigue                    0      0       1      1       1      1      0      0
                    Edema of lower extremities         1      2       0      0       1      2      2      2
                    Fatigue                            1      1       0      0       1      1      0      0
                    Fatigue extreme                    1      1       0      0       1      1      0      0
                    Febrile reaction                   0      0       1      1       1      1      0      0
                    Fever of unknown origin            0      0       1      1       1      1      1      1
                    Infusion site bleeding             0      0       1      1       1      1      0      0
                    Multi-organ failure                0      0       1      1       1      1      0      0
                    Non-cardiac chest pain             0      0       1      1       1      1      1      1
                    Substernal chest pain              0      0       1      1       1      1      0      0
                    Sudden death                       1      1       0      0       1      1      0      0
                    Swelling                           1      1       0      0       1      1      0      0
                    Edema                              0      0       0      0       0      0      1      1
                    Malaise                            0      0       0      0       0      0      1      1
                    Organ failure                      0      0       0      0       0      0      1      1
                    Thrombus in catheter               0      0       0      0       0      0      1      1
                    Ulcer                              0      0       0      0       0      0      1      1
                    Vascular disorders                33      42     27     28      60     70      15     15
                                                    (12.2%)         (9.6%)        (10.9%)        (4.3%)
                    Hypotension                       15      20     13     14      28     34      6      6
                    Hematoma                           2      2       2      2       4      4      0      0
                    Orthostatic hypotension            2      2       2      2       4      4      0      0
                    Deep vein thrombosis leg           3      4       0      0       3      4      0      0
                    Low output state                   3      3       0      0       3      3      0      0
                    Peripheral arterial disease        2      2       1      1       3      3      0      0
                    Claudication                       2      2       0      0       2      2      1      1
                    DVT of legs                        2      2       0      0       2      2      0      0
                    Aortic stenosis                    0      0       1      1       1      1      0      0
                    Arterial thrombosis (limbs)        1      1       0      0       1      1      0      0
                    DVT                                0      0       1      1       1      1      1      1
                    Deep vein thrombosis               0      0       1      1       1      1      0      0
                    Extremity necrosis                 0      0       1      1       1      1      0      0
                    Hemorrhage, unspecified            1      1       0      0       1      1      0      0
                    Hemorrhagic shock                  1      1       0      0       1      1      0      0
                    Hypertension                       0      0       1      1       1      1      1      1
                    Hypovolemic shock                  1      1       0      0       1      1      2      2
                    Labile blood pressure              0      0       1      1       1      1      0      0
                    Peripheral vascular disease        0      0       1      1       1      1      0      0
                    Shock hemorrhagic                  0      0       1      1       1      1      0      0
                    Subclavian artery thrombosis       1      1       0      0       1      1      0      0
                    Thromboembolic event               0      0       1      1       1      1      0      0
                    Bleeding                           0      0       0      0       0      0      1      1
                    Cardiovascular collapse            0      0       0      0       0      0      1      1
                    Hypertensive emergency             0      0       0      0       0      0      1      1

                                                                55

| 54 55 56 57 58 59 60 61 62 63 64 |