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 | – | – | – |