Table 2.
On-therapy adverse events at week 52 (safety population)
| Event | Placebo (n = 101) | Albiglutide 30 mg weekly (n = 101) | Albiglutide 50 mg weekly (n = 99) |
|---|---|---|---|
| Overall (n/%/ratea) | |||
| Any adverse event | 77/76.2/329 | 79/78.2/411 | 81/81.8/349 |
| Serious adverse event | 8/7.9/7.9 | 11/10.9/13.2 | 10/10.1/11.4 |
| Related adverse event | 21/20.8/60.3 | 35/34.7/120 | 36/36.4/94.1 |
| Adverse event leading to withdrawal | 2/2.0/2.0 | 5/5.0/4.7 | 13/13.1/13.4 |
| Most common adverse event (≥6.0% in either albiglutide group), by preferred term (n/%/ratea) | |||
| Injection-site reaction | 2/2.0/29.6 | 9/8.9/35.6 | 14/14.1/34.0 |
| Diarrhoea | 12/11.9/14.8 | 10/9.9 /15.0 | 13/13.1/15.5 |
| Nausea | 8/7.9/7.9 | 10/9.9/11.3 | 9/9.1/10.3 |
| Upper respiratory tract infection | 10/9.9/10.9 | 6/5.9/5.6 | 9/9.1/11.4 |
| Nasopharyngitis | 6/5.9/5.9 | 6/5.9/7.5 | 7/7.1/7.2 |
| Sinusitis | 2/2.0/2.0 | 3/3.0/2.8 | 7/7.1/10.3 |
| Urinary-tract infection | 3/3.0/5.9 | 1/1.0/0.9 | 6/6.1/8.3 |
| Headache | 14/13.9/18.7 | 10/9.9/15.0 | 6/6.1/8.3 |
| GI adverse event (n/%/ratea) | |||
| Any event | 27/26.7/41.4 | 32/31.7/49.7 | 30/30.3/51.6 |
| Gastro-oesophageal reflux disease | 2/2.0/2.0 | 1/1.0/0.9 | 4/4.0/4.1 |
| Constipation | 3/3.0/3.0 | 2/2.0/1.9 | 3/3.0/3.1 |
| Vomiting | 1/1.0/1.0 | 3/3.0/2.8 | 3/3.0/4.1 |
| Dyspepsia | 3/3.0/3.0 | 2/2.0/2.8 | 1/1.0/1.0 |
| Pre-rescue hypoglycaemic event (n/%/rateb) | |||
| Any hypoglycaemic event | 4/4.0/5.65 | 6/5.9/9.46 | 6/6.1/10.09 |
| Severe | 0/0/0 | 0/0/0 | 0/0/0 |
| Documented symptomatic | 2/2.0/2.83 | 1/1.0/2.10 | 0/0/0 |
| ISR, n (%) | |||
| Any ISR | 10 (9.9) | 18 (17.8) | 22 (22.2) |
| Mild ISR eventc | 44 (100) | 82 (90) | 49 (89) |
| Withdrawal due to an ISR | 0 (0) | 4 (4.0) | 4 (4.0) |
| No. of patients with one or two ISR events among patients with an ISR | 8/10 (80) | 9/18 (50) | 15/22 (68) |
aEvent rate per 100 patient-years
bEvent rate per patient-year. American Diabetes Association criteria [16]: Severe—event requiring another person to administer a resuscitative action; Documented symptomatic—plasma glucose concentration ≤3.9 mmol/l (70 mg/dl) and presence of hypoglycaemic symptoms. While analysis of overall hypoglycaemic events was pre-specified, analysis of events that occurred pre-rescue was considered post hoc at the primary endpoint; the number of patients with one or two ISR events was also considered post hoc
cThe bracketed numbers are percentages of mild ISR events with total ISR events as the denominator