Table 2 Summary of adverse events in the safety analysis set
Lanthanum carbonate (n = 23) | Placebo (n = 12) | |||||
|---|---|---|---|---|---|---|
n | (%) | Events | n | (%) | Events | |
Any adverse event | 7 | (30.4) | 15 | 2 | (16.7) | 3 |
Related to investigational product | 2 | (8.7) | 6 | 1 | (8.3) | 1 |
Moderate or severe adverse event | 2 | (8.7) | 4 | – | – | – |
Serious adverse event | 2 | (8.7) | 4 | – | – | – |
Related to investigational product | – | – | – | – | – | – |
Leading to withdrawal of investigational product | 1 | (4.3) | 1 | – | – | – |
Type of adverse event | ||||||
Gastrointestinal disorders | 4 | (17.4) | 4 | 2 | (16.7) | 3 |
Abdominal discomfort | – | – | – | 1 | (8.3) | 1 |
Constipation | 2 | (8.7) | 2 | – | – | – |
Diarrhea | – | – | – | 1 | (8.3) | 1 |
Dry mouth | 1 | (4.3) | 1 | – | – | – |
Acute pancreatitis | 1 | (4.3) | 1 | – | – | – |
Vomiting | – | – | – | 1 | (8.3) | 1 |
Cardiac disorders | 1 | (4.3) | 3 | – | – | – |
Cardiac failure | 1 | (4.3) | 2 | – | – | – |
Myocardial infarction | 1 | (4.3) | 1 | – | – | – |
Other organ system classes | ||||||
Thirst | 1 | (4.3) | 1 | – | – | – |
Bronchitis | 1 | (4.3) | 1 | – | – | – |
Anorexia | 1 | (4.3) | 1 | – | – | – |
Headache | 1 | (4.3) | 1 | – | – | – |
Polyuria | 1 | (4.3) | 1 | – | – | – |
Erythema | 1 | (4.3) | 1 | – | – | – |
Hyperhidrosis | 1 | (4.3) | 1 | – | – | – |
Hypertension | 1 | (4.3) | 1 | – | – | – |