Table 3.
Safety Summary by Treatment Group.
IE (244) | IT (132) | SE (255) | ST (124) | Total (755) | |
---|---|---|---|---|---|
Participants with any event (AE or SAE) | 193(79.1) | 101(76.5) | 187(73.3) | 92(74.2) | 573(75.9) |
With event: Mean (SD) number of events | 3.6 (3.0) | 3.3 (2.4) | 4.1 (3.1) | 3.4 (2.9) | 3.7(2.9) |
Range of events | 1-22 | 1-11 | 1-18 | 1-13 | 1-22 |
Participants with a Serious Adverse Event | 35(14.3) | 18(13.6) | 32(12.5) | 16(12.9) | 101(13.4) |
With SAE: Mean (SD) number of events | 1.3(0.6) | 1.3(0.6) | 1.2(0.4) | 1.3(0.5) | 1.3(0.5) |
Range of events | 1-3 | 1-3 | 1-2 | 1-2 | 1-3 |
Deaths* | 1 | 1 | 2 | 0 | 4 |
Organ Systems of SAE (including deaths)** | 44 | 24 | 38 | 21 | 127 |
Blood and lymphatic system | 1 | 1 | 0 | 1 | 3(2.4) |
16(12.6) | |||||
Cardiac | 5 | 2 | 4 | 5 | |
Eye | 0 | 0 | 0 | 1 | 1(<1) |
Gastrointestinal | 2 | 5 | 0 | 0 | 7(5.5) |
General and administration site | 1 | 0 | 2 | 0 | 3(2.4) |
Immune system | 1 | 0 | 0 | 0 | 1(<1) |
Infections and infestations*** | 9 | 4 | 7 | 3 | 23(18.1) |
Injury and poisoning | 2 | 0 | 1 | 1 | 4(3.1) |
Investigations | 1 | 1 | 1 | 2 | 5(3.9) |
Metabolism and nutrition | 0 | 0 | 0 | 2 | 2(1.6) |
Musculoskeletal and connective tissue | 1 | 0 | 4 | 0 | 5(3.9) |
Neoplasms benign and malignant**** | 5 | 1 | 0 | 1 | 7(5.5) |
Nervous system | 2 | 1 | 3 | 2 | 8(6.3) |
Pregnancy, puerperium and perinatal | 0 | 1 | 1 | 0 | 2(1.6) |
Psychiatric | 3 | 0 | 0 | 1 | 4(3.1) |
Reproductive system and breast | 0 | 0 | 3 | 0 | 3(2.4) |
Respiratory, thoracic and mediastinal | 5 | 0 | 3 | 1 | 9(7.1) |
Surgical and medical procedures | 6 | 5 | 7 | 1 | 19(15.0) |
Vascular | 0 | 3 | 2 | 0 | 5(3.9) |
Three deaths due to cardiac disorders: general (unattended death), coronary heart failure, ventricular septal defect; one due to respiratory failure.
Multiple events per subject; organ system will not necessarily total the sum of the individuals with events as a participant can report more than one event; percents shown are percent of events within a system out of number of events within treatment group.
Twenty-three serious infections were reported (9 in the IE group, 4 IT, 7 SE, 3 ST): 9 Pneumonia (4 IE, 1IT, 4 SE, 2 ST), 3 cellulitis (all IE), and 2 bronchitis (all IT); all other infections 1 per type (3 IE, 1 IT, 3 SE, 2 ST).
Seven malignant diseases were reported (5 in IE, 1 IT, and 1 ST): 2 breast cancer (1 in IT), 3 lung cancer (1 in ST), 1 prostate cancer, and 2 renal carcinoma. None of the reproductive or breast system disorders were breast cancer related.