Table 4.
Adverse events leading to all-cause mortality
| BMI (kg/m2) | ||||
|---|---|---|---|---|
| Underweight (< 18.5) (n = 542) | Normal (18.5 to < 25) (n = 4410) | Overweigh (25 to < 30) (n = 2167) | Obese (≥ 30) (n = 499) | |
| Adverse events | 44 | 72 | 33 | 4 |
| MedDRA System Organ Classa | ||||
| Cardiac disordersb | 12 (2.21) | 13 (0.29) | 8 (0.37) | 1 (0.20) |
| Cancerb | 9 (1.66) | 15 (0.34) | 5 (0.23) | 1 (0.20) |
| Respiratory disordersb | 8 (1.48) | 12 (0.27) | 5 (0.23) | 0 (0) |
| Infectionsb | 5 (0.92) | 14 (0.32) | 2 (0.09) | 2 (0.40) |
| General and whole-body disorders | 3 (0.55) | 6 (0.14) | 5 (0.23) | 0 (0) |
| Renal disorders | 2 (0.37) | 1 (0.02) | 0 (0) | 0 (0) |
| Nervous system disorders | 1 (0.18) | 7 (0.16) | 5 (0.23) | 0 (0) |
| Metabolism and nutrition disorders | 1 (0.18) | 4 (0.09) | 1 (0.05) | 0 (0) |
| Injury, poisoning, and procedural complications | 1 (0.18) | 3 (0.07) | 1 (0.05) | 0 (0) |
| Vascular disorders | 0 (0) | 0 (0) | 2 (0.09) | 0 (0) |
Data are presented as n (%). MedDRA terms with ≥ 2 events in either BMI categories are shown
BMI body mass index, MedDRA Medical Dictionary for Regulatory Activities
aBased on MedDRA version 20.0
bThe terms used in MedDRA are as follows: cancer, neoplasms benign, malignant, and unspecified (including cysts and polyps); infections, infections and infestations; respiratory disorders, respiratory, thoracic, and mediastinal disorders