TABLE 2.
Summary of adverse events through 52 weeks in the <65 and ≥65 year subgroups
| Age group | <65 years | ≥65 years | |||||
|---|---|---|---|---|---|---|---|
| Variable, n (%) |
DU 1.5 mg (N = 456) |
DU 3.0 mg (N = 466) |
DU 4.5 mg (N = 482) |
DU 1.5 mg (N = 156) |
DU 3.0 mg (N = 150) |
DU 4.5 mg (N = 132) |
Interaction P value |
| Composite incidence of nausea, vomiting and diarrhoea | 93 (20.4) | 115 (24.7) | 140 (29.0) | 35 (22.4) | 39 (26.0) | 31 (23.5) | .383 |
| Nausea | 62 (13.6) | 76 (16.3) | 90 (18.7) | 25 (16.0) | 23 (15.3) | 16 (12.1) | .201 |
| Vomiting | 29 (6.4) | 40 (8.6) | 48 (10.0) | 10 (6.4) | 16 (10.7) | 14 (10.6) | .887 |
| Diarrhoea | 34 (7.5) | 57 (12.2) | 61 (12.7) | 13 (8.3) | 17 (11.3) | 10 (7.6) | .366 |
| Dyspepsia | 13 (2.9) | 18 (3.9) | 14 (2.9) | 4 (2.6) | 13 (8.7) | 3 (2.3) | .229 |
| Nasopharyngitis | 19 (4.2) | 22 (4.7) | 27 (5.6) | 9 (5.8) | 10 (6.7) | 11 (8.3) | .988 |
| TEAEs related to supraventricular arrythmias, conduction disorders and adjudicated CV events | 22 (4.8) | 23 (4.9) | 24 (5.0) | 12 (7.7) | 11 (7.3) | 9 (6.8) | .963 |
| Overall discontinuation of study drug | 56 (12.3) | 75 (16.1) | 74 (15.4) | 23 (14.7) | 18 (12.0) | 20 (15.2) | .366 |
| Discontinuation of study drug because of an AE | 23 (5.0) | 33 (7.1) | 39 (8.1) | 14 (9.0) | 10 (6.7) | 13 (9.8) | .417 |
| Nausea | 2 (0.4) | 6 (1.3) | 7 (1.5) | 6 (3.8) | 2 (1.3) | 2 (1.5) | .124 |
| Diarrhoea | 1 (0.2) | 4 (0.9) | 6 (1.2) | 0 (0) | 2 (1.3) | 0 (0) | .548 |
| Vomiting | 0 (0) | 2 (0.4) | 8 (1.7) | 0 (0) | 3 (2.0) | 0 (0) | .194 |
| Overall serious adverse events | 34 (7.5) | 35 (7.5) | 24 (5.0) | 17 (10.9) | 7 (4.7) | 14 (10.6) | .057 |
| Hypoglycaemia incidences | |||||||
| Total a | 30 (6.6) | 22 (4.7) | 22 (4.6) | 13 (8.3) | 11 (7.3) | 15 (11.4) | .422 |
| Documented symptomatic (≤70 mg/dL) | 15 (3.3) | 10 (2.2) | 11 (2.3) | 4 (2.6) | 5 (3.3) | 8 (6.1) | .293 |
Note: Data presented as n (%).
Abbreviations: AE, adverse event; CV, cardiovascular; DU, dulaglutide; n, sample size; N, population size; TEAEs, treatment‐emergent adverse events.
a
Total hypoglycaemic incidences = any episode with plasma glucose level below the defined threshold (≤70 mg/dL), regardless of symptoms, an episode of symptomatic hypoglycaemia where plasma glucose level was not measured and all severe hypoglycaemia episodes.