Table 4.
Cumulative subjects (%) reporting AEIs (italic) and/or other AEs post dose 2 over the study period (Safety Set)
| MedDRA Primary System Organ Class (CODE) | Spain [N = 139] | |
|---|---|---|
| Preferred Term (Code) | n | % [95% CI (LL-UL)] |
| Any | 33 | 23.7 [16.1–32.9] |
| Any respiratory, thoracic and mediastinal disorders (10038738) | 19 | 13.7 [6.0–25.3] |
| Cough (10011224) | 13 | 9.4 [2.7–22.1] |
| Rhinorrhoea (10039101) | 10 | 7.2 [0.5–27.2] |
| Nasal congestion (10028735) | 4 | 2.9 [0.3–10.5] |
| Dysphonia (10013952) | 3 | 2.2 [0.3–7.5] |
| Wheezing (10047924) | 2 | 1.4 [0.0–11.5] |
| Epistaxis (10015090) | 1 | 0.7 [0.0–3.9] |
| Sneezing (10041232) | 1 | 0.7 [0.0–3.9] |
| Oropharyngeal pain (10068319) | 0 | 0.0 [0.0–2.6] |
| Any general disorders and administration site conditions (10018065) | 13 | 9.4 [4.7–16.3] |
| Injection site pain (10022086) | 7 | 5.0 [2.1–10.1] |
| Pyrexia (10037660) | 7 | 5.0 [1.0–14.3] |
| Chills (10008531) | 0 | 0.0 [0.0–2.6] |
| Face oedema (10016029) | 0 | 0.0 [0.0–2.6] |
| Fatigue (10016256) | 1 | 0.7 [0.0–3.9] |
| Injection site erythema (10022061) or swelling (10053425) | 0 | 0.0 [0.0–2.6] |
| Any infections and infestations (10021881) | 4 | 2.9 [0.6–8.3] |
| Conjunctivitis (10010741) | 3 | 2.2 [0.4–6.2] |
| Rhinitis (10039083) | 1 | 0.7 [0.0–3.9] |
| Any gastrointestinal disorders (10017947) | 4 | 2.9 [0.0–22.0] |
| Diarrhoea (10012735) | 2 | 1.4 [0.0–11.5] |
| Vomiting (10047700) | 1 | 0.7 [0.0–25.0] |
| Abdominal pain (10000081) | 1 | 0.7 [0.0–3.9] |
| Nausea (10028813) | 0 | 0.0 [0.0–2.6] |
| Any metabolism and nutrition disorders (10027433) | 3 | 2.2 [0.4–6.2] |
| Decreased appetite (10061428) | 3 | 2.2 [0.4–6.2] |
| Any psychiatric disorders (10037175) | 4 | 2.9 [0.3–10.5] |
| Irritability (10022998) | 4 | 2.9 [0.3–10.5] |
| Any eye disorders (10015919) | 2 | 1.4 [0.2–5.1] |
| Eye pruritus (10052140) | 2 | 1.4 [0.2–5.1] |
| Any musculoskeletal and connective tissue disorders (10028395) | 1 | 0.7 [0.0–3.9] |
| Myalgia (10028411) | 1 | 0.7 [0.0–3.9] |
| Arthropathy (10003285) | 0 | 0.0 [0.0–2.6] |
| Any skin and subcutaneous tissue disorders (10040785) | 1 | 0.7 [0.0–3.9] |
| Rash (10037844) | 1 | 0.7 [0.0–3.9] |
| Rash generalized (10037858) | 0 | 0.0 [0.0–2.6] |
| Any immune system disorders (10021428) | 0 | 0.0 [0.0–2.6] |
| Anaphylaxis (10002198) or Hypersensitivity (10020751) | 0 | 0.0 [0.0–2.6] |
| Any nervous system disorders (10029205) | 0 | 0.0 [0.0–2.6] |
| Febrile convulsion (10016284) or Headache (10019211) | 0 | 0.0 [0.0–2.6] |
Bold values represent the MedDRA Primary System Organ Class (SOC)
Italic values represent Preferred Terms which corresponds to the pre-defined AEIs
Plain values represent Preferred Terms which corresponds to other AEs captured beyond the initial pre-defined AEIs
AE adverse event, AEI adverse event of interest, MedDRA Medical Dictionary for Regulatory Activities, N total number of subjects, n (%) number (percentage) of subjects reporting the symptom at least once, 95% CI 95% confidence interval (extended Clopper–Pearson exact CI for cluster data), LL lower limit, UL upper limit