Table 3.
Adverse events summary, specific AEs by SOC with incidence ≥5% and incidences of symptomatic hypoglycemia in the omarigliptin/omarigliptin treatment group through week 52 in the overall population and for each background AHA stratum
| Patients, n (%) | Sulfonylurea + omarigliptin (through week 52) n = 126 |
Glinide + omarigliptin (through week 52) n = 65 |
Biguanide + omarigliptin (through week 52) n = 66 |
Thiazolidinedione+ omarigliptin (through week 52) n = 65 |
α-Glucosidase inhibitor + omarigliptin (through week 52) n = 67 |
Overall + omarigliptin (through week 52) n = 389 |
|---|---|---|---|---|---|---|
| With one or more | ||||||
| AEs | 96 (76.2) | 49 (75.4) | 53 (80.3) | 55 (84.6) | 46 (68.7) | 299 (76.9) |
| Drug-relateda AEs | 11 (8.7) | 7 (10.8) | 2 (3.0) | 4 (6.2) | 0 (0.0) | 24 (6.2) |
| Serious AEs | 6 (4.8) | 3 (4.6) | 2 (3.0) | 4 (6.2) | 1 (1.5) | 16 (4.1) |
| Serious drug-relateda AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Who died | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Who discontinued due to | ||||||
| An AE | 1 (0.8) | 3 (4.6) | 1 (1.5) | 4 (6.2) | 0 (0.0) | 9 (2.3) |
| A drug-relateda AE | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 2 (0.5) |
| A serious AE | 1 (0.8) | 2 (3.1) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 4 (1.0) |
| A serious drug-relateda AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| With specific AEs with incidence ≥5% in ≥1 treatment group, by SOCb | ||||||
| Gastrointestinal disorders | ||||||
| Constipation | 7 (5.6) | 5 (7.7) | 1 (1.5) | 1 (1.5) | 2 (3.0) | 16 (4.1) |
| Infections and infestations | ||||||
| Bronchitis | 10 (7.9) | 1 (1.5) | 0 (0.0) | 2 (3.1) | 3 (4.5) | 16 (4.1) |
| Gastroenteritis | 2 (1.6) | 0 (0.0) | 4 (6.1) | 1 (1.5) | 1 (1.5) | 8 (2.1) |
| Influenza | 4 (3.2) | 0 (0.0) | 0 (0.0) | 4 (6.2) | 1 (1.5) | 9 (2.3) |
| Nasopharyngitis | 34 (27.0) | 23 (35.4) | 24 (36.4) | 19 (29.2) | 19 (28.4) | 119 (30.6) |
| Metabolism and nutrition disorders | ||||||
| Hypoglycemia | 11 (8.7) | 2 (3.1) | 3 (4.5) | 2 (3.1) | 0 (0.0) | 18 (4.6) |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1 (0.8) | 5 (7.7) | 1 (1.5) | 3 (4.6) | 1 (1.5) | 11 (2.8) |
| Back pain | 6 (4.8) | 4 (6.2) | 4 (6.1) | 5 (7.7) | 4 (6.0) | 23 (5.9) |
| Nervous system disorders | ||||||
| Headache | 2 (1.6) | 0 (0.0) | 2 (3.0) | 4 (6.2) | 3 (4.5) | 11 (2.8) |
| With one or more AE of symptomatic hypoglycemiac | 10 (7.9) | 2 (3.1) | 2 (3.0) | 1 (1.5) | 0 (0.0) | 15 (3.9) |
aAssessed by the investigator to be related to the drug
bSystem organ class defined by the Medical Dictionary for Regulatory Activities (MedDRA) classification system
cPrespecified AE of interest; symptomatic hypoglycemia: episode with clinical symptoms consistent with hypoglycemia, without regard to glucose level