Table 2.
Incidences of one or more adverse event or serious adverse event per 100 patient-years (PY) during the safety perioda (safety population)
| All events |
Events with suspected relation to study drug |
|||||
|---|---|---|---|---|---|---|
| High ferritin FCM (n = 154) (138.5 PY) |
Low ferritin FCM (n = 150) (129.0 PY) |
Oral iron (n = 312) (242.8 PY) |
High ferritin FCM (n = 154) (138.5 PY) |
Low ferritin FCM (n = 150) (129.0 PY) |
Oral iron (n = 312) (242.8 PY) |
|
| Adverse events (per 100 PY) | 91.0 | 100.0 | 105.0 | 15.9 | 17.8 | 36.7 |
| No. patients with any adverse event (%) | 126 (81.8) | 129 (86.0) | 255 (81.7) | 22 (14.3) | 23 (15.3) | 89 (28.5) |
| Median time (days) to first event | 46 | 57 | 35 | 148 | 111 | 29 |
| Gastrointestinal disorders (per 100 PY) | 23.1 | 29.5 | 52.7 | 3.6 | 4.7 | 26.8 |
| Diarrhea | 10.8 | 8.5 | 18.5 | 1.4 | – | 7.8 |
| Constipation | 1.4 | 3.9 | 15.2 | 0.7 | 0.8 | 11.5 |
| Nausea | 6.5 | 5.4 | 6.2 | 0.7 | 1.6 | 2.9 |
| Vomiting | 4.3 | 3.1 | 5.4 | – | – | 0.8 |
| Dyspepsia | 1.4 | 2.3 | 7.0 | – | 0.8 | 3.7 |
| Infections (per 100 PY) | 36.8 | 39.5 | 39.1 | 2.9 | 1.6 | 2.9 |
| Urinary tract infection | 13.0 | 7.8 | 7.0 | 0.7 | – | 0.4 |
| Nasopharyngitis | 9.4 | 7.8 | 6.6 | 0.7 | – | 0.4 |
| Influenza | 2.9 | 6.2 | 2.9 | 0.7 | – | 0.8 |
| General disorders and administrative site conditions (per 100 PY) | 26.0 | 27.1 | 27.6 | 2.9 | 2.3 | 1.2 |
| Peripheral edema | 15.2 | 16.3 | 11.9 | 0.7 | – | 0.8 |
| Fatigue | 0.7 | 4.7 | 5.8 | – | 1.6 | – |
| Musculoskeletal and connective tissue disorders (per 100 PY) | 25.3 | 32.6 | 23.1 | 3.6 | 2.3 | 2.9 |
| Back pain | 10.8 | 9.3 | 4.5 | – | 0.8 | 0.4 |
| Arthralgia | 7.2 | 5.4 | 6.2 | – | – | 0.4 |
| Pain in extremity | 1.4 | 6.2 | 6.2 | – | 0.8 | 0.8 |
| Muscle spasms | 0.7 | 5.4 | 1.2 | 0.7 | – | – |
| Metabolism and nutrition disorders (per 100 PY) | 22.4 | 24.8 | 25.5 | – | 0.8 | 2.9 |
| Hypoglycemia | 5.1 | 3.9 | 4.5 | – | – | – |
| Hyperkalemia | 3.6 | 5.4 | 2.9 | – | – | – |
| Hyperglycemia | 5.1 | 0 | 2.1 | – | – | 0.4 |
| Vascular disorders (per 100 PY) | 23.8 | 20.2 | 21.4 | 2.9 | 1.6 | 0.8 |
| Hypertension | 15.2 | 10.9 | 13.2 | 2.2 | 0.8 | 0.4 |
| Hypotension | 5.8 | 3.1 | 2.1 | 0.7 | – | – |
| Respiratory, thoracic and mediastinal disorders (per 100 PY) | 13.7 | 20.9 | 16.9 | 0.7 | 0.8 | 1.2 |
| Dyspnea | 5.1 | 8.5 | 4.5 | – | 0.8 | 0.4 |
| Nervous system disorders (per 100 PY) | 18.1 | 21.7 | 13.6 | 2.9 | 3.9 | 2.1 |
| Dizziness | 6.5 | 6.2 | 2.9 | 0.7 | 0.8 | 0.4 |
| Headache | 4.3 | 7.8 | 2.9 | – | 0.8 | 0.8 |
| Investigations (per 100 PY) | 15.9 | 15.5 | 17.7 | 2.9 | – | 2.1 |
| Injury, poisoning and procedural complications (per 100 PY) | 12.3 | 17.1 | 12.8 | 0.7 | 1.6 | – |
| Cardiac disorders (per 100 PY) | 15.2 | 10.9 | 11.9 | 1.4 | 0.8 | – |
| Renal and urinary disorders (per 100 PY) | 11.6 | 8.5 | 14.0 | – | 0.8 | – |
| Skin and subcutaneous tissue disorders (per 100 PY) | 11.6 | 9.3 | 13.2 | – | 0.8 | – |
| Blood and lymphatic system disorders | 5.8 | 8.5 | 5.4 | 0.7 | 1.6 | – |
| Anemia (per 100 PY) | 5.1 | 6.2 | 4.1 | 0.7 | 1.6 | – |
| Neoplasms benign, malignant and unspecified (including cysts and polyps)b (per 100 PY) | 8.7 | 3.9 | 3.3 | – | 0.8 | – |
| Serious adverse events (per 100 PY) | 28.2 | 27.9 | 24.3 | – | – | 0.4 |
| No. of patients with any serious adverse event (%) | 39 (25.3) | 36 (24.0) | 59 (18.9) | 0 | 0 | 1 (0.3) |
| Median time (days) to first event | 143 | 134 | 67 | – | – | 3 |
| Cardiac disorders (per 100 PY) | 7.2 | 5.4 | 5.8 | – | – | – |
| Acute myocardial infarction | 1.4 | – | 1.6 | |||
| Cardiac failure | 0.7 | – | 1.2 | |||
| Cardiac failure congestive | 1.4 | 0.8 | 0.4 | |||
| Acute coronary syndrome | 1.4 | – | 0.4 | |||
| Infections (per 100 PY) | 4.3 | 3.9 | 4.9 | – | – | – |
| Pneumonia | – | 0.8 | 1.6 | |||
| Renal and urinary disorders (per 100 PY) | 4.3 | 1.6 | 5.4 | – | – | – |
| Chronic renal failure | 0.7 | 0.8 | 2.5 | |||
| Musculoskeletal and connective tissue disorders (per 100 PY) | 1.4 | 2.3 | 1.2 | – | – | – |
| Back pain | 1.4 | 0.8 | – | |||
| Metabolism and nutrition disorders | 2.9 | 4.7 | 2.9 | – | – | – |
| Hypoglycemia (per 100 PY) | 0.7 | 0.8 | 2.1 | |||
| Diabetes mellitus | – | 2.3 | 0.4 | |||
| Nervous system disorders (per 100 PY) | 1.4 | 0.8 | 2.5 | – | – | – |
| Syncope | – | – | 1.2 | |||
The safety population included all patients who received one or more doses of randomized treatment.
aThe safety period included all events up to the point at which another anemia therapy was initiated and/or the randomized study medication was discontinued.
bAll events to final follow-up are included.