Table 5.
Cumulative subjects (%) reporting AEIs (italic) and/or other AEs post dose 1 and dose 2 over the study period – Spain (Safety Set)
| MedDRA Primary System Organ Class (CODE) Preferred Term (Code) |
Spain [N = 453] | ||
|---|---|---|---|
| n | n | % [95% CI (LL–UL)] | |
| Any | 669 | 227 | 50.1 [29.1–71.1] |
| Any general disorders and administration site conditions (10018065) | 233 | 146 | 32.2 [11.9–59.1] |
| Injection site pain (10022086) | 83 | 82 | 18.1 [2.3–51.5] |
| Pyrexia (10037660) | 36 | 35 | 7.7 [2.2–18.4] |
| Fatigue (10016256) | 36 | 34 | 7.5 [1.2–22.8] |
| Injection site swelling (10053425) | 33 | 33 | 7.3 [1.7–18.9] |
| Injection site erythema (10022061) | 25 | 25 | 5.5 [2.4–10.6] |
| Chills (10008531) | 13 | 13 | 2.9 [0.3–10.1] |
| Face edema (10016029) | 1 | 1 | 0.2 [0.0–2.3] |
| Mucous membrane disorder (10028133) | 2 | 2 | 0.4 [0.1–1.6] |
| 1 each (n): discomfort (10013082); influenza-like illness (10022004); injection site pruritus (10022093); peripheral swelling (10048959)a | 1 | 1 | 0.2 [0.0–4.8/7.3a] |
| Any respiratory, thoracic and mediastinal disorders (10038738) | 212 | 116 | 25.6 [12.5–42.9] |
| Cough (10011224) | 61 | 57 | 12.6 [2.8–32.2] |
| Rhinorrhea (10039101) | 57 | 52 | 11.5 [5.0–21.6] |
| Nasal congestion (10028735) | 41 | 40 | 8.8 [6.2–12.2] |
| Oropharyngeal pain (10068319) | 26 | 26 | 5.7 [1.3–15.2] |
| Dysphonia (10013952) | 13 | 13 | 2.9 [1.2–5.6] |
| Epistaxis (10015090) | 5 | 5 | 1.1 [0.0–5.7] |
| Wheezing (10047924) | 4 | 4 | 0.9 [0.2–2.3] |
| Sneezing (10041232) | 3 | 3 | 0.7 [0.0–6.9] |
| 1 each: Increased upper airway secretion (10062717); Throat clearing (10080125)b | 1 | 1 | 0.2 [0.0–2.3/4.8b] |
| Any musculoskeletal and connective tissue disorders (10028395) | 45 | 39 | 8.6 [0.4–35.5] |
| Myalgia (10028411) | 32 | 32 | 7.1 [0.5–26.6] |
| Arthropathy (10003285) | 11 | 11 | 2.4 [0.0–29.2] |
| 1 each: Pain in extremity (10033425); Synovial cyst (10042858)c | 1 | 1 | 0.2 [0.0–2.3/4.8c] |
| Any nervous system disorders (10029205) | 37 | 36 | 8.0 [0.6–29.7] |
| Headache (10019211) | 34 | 33 | 7.3 [1.1–22.5] |
| 1 each: Aphonia (10002953); Dizziness (10013573); Somnolence (10041349) | 1 | 1 | 0.2 [0.0–4.8] |
| Febrile convulsion (10016284) | 0 | 0 | 0.0 [0.0–0.8] |
| Any gastrointestinal disorders (10017947) | 53 | 32 | 7.1 [4.7–10.1] |
| Diarrhoea (10012735) | 20 | 18 | 4.0 [2.4–6.2] |
| Vomiting (10047700) | 15 | 15 | 3.3 [0.2–13.6] |
| Nausea (10028813) | 13 | 13 | 2.9 [0.3–10.1] |
| Abdominal pain (10000081) | 4 | 4 | 0.9 [0.0–9.1] |
| Abdominal discomfort (10000059) | 1 | 1 | 0.2 [0.0–4.8] |
| Any infections and infestations (10021881) | 36 | 33 | 7.3 [1.2–22.0] |
| Conjunctivitis (10010741) | 16 | 16 | 3.5 [0.3–14.3] |
| Rhinitis (10039083) | 14 | 14 | 3.1 [0.2–12.9] |
| 1 each (n): Bronchitis (10006451); Ear infection (10014011); Hordeolum (10020377)d; Laryngitis (10023874)d; Nasopharyngitis (10028810)d; Upper respiratory tract infection (10046306) | 1 | 1 | 0.2 [0.0–2.3/7.3d] |
| Any metabolism and nutrition disorders (10027433) | 27 | 26 | 5.7 [0.2–26.1] |
| Decreased appetite (10061428) | 27 | 26 | 5.7 [0.2–26.1] |
| Any psychiatric disorders (10037175) | 16 | 13 | 2.9 [0.8–7.1] |
| Irritability (10022998) | 15 | 13 | 2.9 [0.8–7.1] |
| Mood swings (10027951) | 1 | 1 | 0.2 [0.0–4.8] |
| Any skin and subcutaneous tissue disorders (10040785) | 7 | 7 | 1.6 [0.0–11.4] |
| Rash (10037844) | 5 | 5 | 1.1 [0.0–7.8] |
| Erythema (10015150), | 2 | 2 | 0.4 [0.0–4.0] |
| Rash generalized (10037858) | 0 | 0 | 0.0 [0.0–0.8] |
| Any ear and labyrinth disorders (10013993) | 1 | 1 | 0.2 [0.0–2.3] |
| Ear pain (10014020) | 1 | 1 | 0.2 [0.0–2.3] |
| Any immune system disorders (10021428) | 0 | 0 | 0.0 [0.0–0.8] |
| Hypersensitivity (10020751) | 0 | 0 | 0.0 [0.0–0.8] |
| Anaphylactic reaction (10002198) | 0 | 0 | 0.0 [0.0–0.8] |
| Any eye disorders (10015919) | 2 | 2 | 0.4 [0.0–4.6] |
| Eye pruritus (10052140) | 2 | 2 | 0.4 [0.0–4.6] |
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 of specified AEs reported considering both AERCs, 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, AERCs adverse event reporting cards
a,b,c,d95% CI UL for the specified AEs