Table 7.
Treatment-emergent AEs leading to patient withdrawal in the safety population
| Treatment Arm
|
|||
|---|---|---|---|
| Placebo | Fermagate 1 g | Fermagate 2 g | |
| No of patients discontinuing due to an AE | 6 | 1 | 13 |
| AEs (number of AEs) | |||
| Diarrhea | 1 | 0 | 9 |
| Discolored feces | 1 | 1 | 5 |
| Nausea | 1 | 0 | 2 |
| Dyspepsia | 0 | 0 | 2 |
| Gastric disorder/irritation | 2 | 0 | 0 |
| Vomiting | 0 | 0 | 2 |
| Anorexia | 1 | 0 | 1 |
| Abdominal distension | 0 | 0 | 1 |
| Fecal incontinence | 0 | 0 | 1 |
| Loose stools | 0 | 1 | 0 |
| Rectal hemorrhage | 1 | 0 | 0 |
| Retching | 0 | 0 | 1 |
| Acute myocardial infarction | 1 | 0 | 0 |
| Chest pain | 0 | 0 | 1 |
| Arteriovenous fistula occlusion | 0 | 0 | 1 |
| Blood magnesium increased | 0 | 0 | 1 |
| Hypermagnesemia | 0 | 0 | 1 |
| Increased blood phosphatea | 1 | 0 | 0 |
a
Recorded during the follow-up period.