Table 2. Common Adverse Events and Serious Adverse Eventsa,b.
| Patients Who Had Adverse Event, No. (%) | ||
|---|---|---|
| Lanreotide Group (n = 153) |
Control Group (n = 152) |
|
| Adverse events | ||
| Any adverse event | 153 (100) | 151 (99) |
| Adverse event leading to withdrawal | 16 (10) | 0 |
| Specific adverse events | ||
| Abnormal feces | 139 (91) | 10 (6.6) |
| Abdominal discomfort | 121 (79) | 30 (20) |
| Fatigue | 64 (42) | 32 (21) |
| Injection site discomfort | 49 (32) | 1 (0.7) |
| Nausea | 45 (29) | 7 (4.6) |
| Dizziness | 31 (20) | 12 (7.9) |
| Flatulence | 27 (18) | 0 |
| Bradycardia | 23 (15) | 9 (5.9) |
| Alopecia | 16 (10) | 0 |
| Chest pain | 12 (7.8) | 2 (1.3) |
| Decreased appetite | 11 (7.2) | 1 (0.7) |
| Injection papule | 9 (5.9) | 0 |
| Glycated hemoglobin increased | 8 (5.2) | 1 (0.7) |
| Influenza-like illness | 31 (20) | 46 (30) |
| Nasopharyngitis | 19 (12) | 37 (24) |
| Serious adverse events | ||
| Any serious adverse event | 43 (28) | 19 (12.5) |
| Serious adverse event leading to withdrawal | 4 (2.6) | 2 (1.3) |
| Specific serious adverse events | ||
| Hepatic cyst infectionc | 8 (5.2) | 0 |
| Renal cyst infection | 3 (2) | 3 (2) |
| Pyelonephritis | 2 (1.3) | 1 (0.7) |
| Epigastric pain | 2 (1.3) | 0 |
| Fever | 2 (1.3) | 0 |
| Urinary tract infection | 1 (0.7) | 2 (1.3) |
| Pancreatitis | 1 (0.7) | 0 |
| Cholelithiasis | 1 (0.7) | 0 |
Listed are all adverse events with an incidence >5% that occurred significantly more often in the lanreotide or control group, and serious adverse events with an incidence >2% or that were at least possibly related to lanreotide treatment.
Adverse events were collected by spontaneous report. A full list of adverse events as well as of serious adverse events is provided as eTables 4 and 5 in Supplement 3. Adverse events were categorized according to the preferred terms of the Medical Dictionary for Regulatory Activities.
There were 8 patients with 9 instances of hepatic cyst infections. In 2 of these patients, this event led to treatment withdrawal. In the other 6 patients, treatment was withdrawn later by the investigator because of a protocol amendment.