Table 2. Characteristics of probable and definite infections in the cohort.
| Number of potential ADRs (n, %) | N of occurrences per patient (median, IQR)a | Impact score (median, IQR) | Time between start biological and potential ADR (months) (median, IQR)b | Duration (days) (median, IQR)b |
Contact HCP (n, %) | Hospitalization (n, %) | |
|---|---|---|---|---|---|---|---|
| All definite and probable potential infectious ADRsc |
421 | 3.0 (2.0–8.0) | 3.0 (2.0–4.0) | 18.0 (2.0–72.0) | 31.0 (13.0–64.0) | 207 (49.3) | 8 (1.9) |
| All definite potential infectious ADRsc |
358 (41.29) | 3.0 (2.0–5.0) | 3.0 (2.0–4.0) | 20.0 (4.0–69.0) | 31.0 (12.5–52.3) | 173 (48.3) | 8 (2.2) |
| All probable potential infectious ADRsc |
63 (7.27) | 2.0 (1.0–5.0) | 3.0 (2.0–3.0) | 6.0 (0.0–80.0) | 28.0 (16.0–48.0) | 34 (54.0) | 0 (0) |
ADR = adverse drug reaction, HCP = Healthcare provider, IQR = interquartile range, PT = MedDRA Preferred Term.
aIn a total of 156 patients reporting a possible, probable or definite infection ADR.
bWhen calculating the time between the start of the biological and the first occurrence of the potential ADR and the duration of the potential ADR, we used start dates provided by the participants. However, in a large proportion of cases, stop dates for potential ADRs were missing because of loss to follow-up or a constantly recurring/chronic infection without a stop date. For the purposes of calculating potential ADR duration in this table, we only used potential ADRs that had an available stop date.
cAll potential ADRs: The total number of probable or definite potential infectious ADRs mentioned by all patients in all questionnaires (potential ADRs are counted each time when mentioned in a questionnaire by a patient).