Table 4.
Exacerbations and adverse events
| FCM (n=24) | Placebo (n=24) | P value | |||
| Participants, n (%) | Events (n) | Participants, n (%) | Events (n) | ||
| Exacerbations | 7 (29.2) | 7 | 7 (29.2) | 12 | 1.00 |
| Use of antibiotics | 6 (25.0) | 6 | 5 (20.8) | 8 | 0.73 |
| Use of steroids | 5 (20.8) | 5 | 5 (20.8) | 6 | 1.00 |
| Adverse events, all | 22 (91.7) | 48 | 17 (70.8) | 28 | 0.14 |
| Hypophosphataemia* | 22 (91.7) | 22 | 2 (8.3) | 2 | <0.001 |
| Other abnormal laboratory tests† | 8 (33.3) | 10 | 7 (29.2) | 8 | 0.76 |
| Hypertension‡ | 5 (20.8) | 5 | 4 (16.7) | 4 | 1.00 |
| Dyspnoea | 3 (12.5) | 3 | 0 | 0 | 0.23 |
| Headache | 2 (8.3) | 2 | 4 (16.7) | 4 | 0.67 |
| Haematoma | 2 (8.3) | 2 | 2 (8.3) | 2 | 1.00 |
| Fever | 1 (4.2) | 1 | 0 | 0 | 1.00 |
| Rash | 1 (4.2) | 1 | 0 | 0 | 1.00 |
| Upper respiratory infection | 1 (4.2) | 1 | 0 | 0 | 1.00 |
| Cough | 1 (4.2) | 1 | 0 | 0 | 1.00 |
| Nasal congestion | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Lung infection | 0 | 0 | 1 (4.2) | 2 | 1.00 |
| Vomiting | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Diarrhoea | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Dyspepsia | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Dizziness | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Fall | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Serious adverse events, all | 0 | 0 | 2 (8.3) | 2 | 0.49 |
| Lung infection, requiring hospitalisation | 0 | 0 | 1 (4.2) | 1 | 1.00 |
| Fall, requiring hospitalisation | 0 | 0 | 1 (4.2) | 1 | 1.00 |
Adverse events were recorded up to 1 week postinfusion and coded using CTCAE. Serious adverse events were recorded for the entire study duration. Pre-existing events were not considered adverse events unless they changed in severity (increase by one grade or more) or frequency. The total number of participants with adverse events does not correspond to the sum of the number of participants with a particular adverse event as some participants had multiple adverse events.
P values were calculated using χ2 or Fisher’s exact tests for differences in the number of participants with a given event.
*Hypophosphataemia was defined as phosphate levels <0.8 mmol/L. Phosphate levels were routinely measured in only 29 participants during the study (14 of those received FCM). Numbers reported here are based on the retrospective analysis of stored serum samples from all participants.
†These included, in order of frequency, elevated C reactive protein, hypoalbuminaemia, thrombocytosis, hypokalaemia, anaemia, hyperkalaemia, elevated white cell and neutrophil counts (no significant between-group differences for any of those values).
‡Hypertension was considered an adverse event if the elevated blood pressure was not pre-existent (ie, the grade of hypertension as defined by CTCAE observed immediately postinfusion or at week 1 was not present on any occasion prior to infusion) or was pre-existent but worsened (ie, an increase by at least one grade as defined by CTCAE immediately postinfusion or at week 1).
CTCAE, Common Terminology Criteria for Adverse Events; FCM, ferric carboxymaltose.