Table 3.
Cumulative subjects (%) reporting AEIs (italic) and/or other AEs post dose 1 over the study period (Safety Set)
| MedDRA Primary System Organ Class (CODE) Preferred Term (Code) |
Belgium [N = 329] | Germany [N = 278] | Spain [N = 453] | Total [N = 1060] | |
|---|---|---|---|---|---|
| Any |
n (%) 95% CI, LL–UL |
139 (42.3) 22.2–64.3 |
102 (36.7) 15.8–62.0 |
215 (47.5) 23.2–72.6 |
456 (43.0) 36.8–49.4 |
| Any general disorders and administration site conditions (10018065) |
n (%) 95% CI, LL–UL |
88 (26.8) 6.3–59.0 |
77 (27.7) 14.7–44.2 |
137 (30.2) 7.3–64.2 |
302 (28.5) 21.8–35.9 |
| Injection site pain (10022086) |
65 (19.8) 1.3–62.8 |
46 (16.6) 5.7–34.1 |
76 (16.8) 1.0–56.7 |
187 (17.6) 11.2–25.8 |
|
| Injection site swelling (10053425) |
17 (5.2) 3.0–8.1 |
30 (10.8) 7.3–15.2 |
33 (7.3) 1.7–18.9 |
80 (7.6) 5.4–10.2 |
|
| Fatigue (10016256) |
13 (4.0) 0.6–12.7 |
22 (7.9) 2.3–18.5 |
34 (7.5) 1.2–22.8 |
69 (6.5) 4.0–9.9 |
|
| Injection site erythema (10022061) |
10 (3.0) 0.0–18.7 |
21 (7.6) 1.5–21.3 |
25 (5.5) 2.4–10.6 |
56 (5.3) 3.5–7.6 |
|
| Pyrexia (10037660) |
2 (0.6) 0.0–6.0 |
2 (0.7) 0.0–14.0 |
29 (6.4) 3.0–11.8 |
33 (3.1) 0.9–7.5 |
|
| Chills (10008531) |
5 (1.5) 0.0–7.9 |
7 (2.5) 0.0–28.3 |
13 (2.9) 0.3–10.1 |
25 (2.4) 1.1–4.4 |
|
| Injection site pruritus (10022093) |
1 (0.3) 0.0–3.9 |
3 (1.1) 0.0–13.1 |
1 (0.2) 0.0–4.8 |
5 (0.5) 0.1–1.7 |
|
| Face oedema (10016029) |
1 (0.3) 0.0–9.8 |
0 (0.0) 0.0–1.3 |
1 (0.2) 0.0–2.3 |
2 (0.2) 0.0–0.7 |
|
| Influenza-like illness (10022004); mucous membrane disorder (10028133); peripheral swelling (10048959) |
n = 1; 0; 1 NR |
n = 0; 0; 0 NR |
n = 1; 2; 1 NR |
2 (0.2) each NR |
|
| Discomfort (10013082); feeling cold (10016326); feeling hot (10016334); injection site hematoma (10022066); injection site warmth (10022112); malaise (10025482) |
n = 0; 1; 1; 0; 1; 0 NR |
n = 0; 0; 0; 1; 0; 1 NR |
n = 1; 0; 0; 0; 0; 0 NR |
1 (0.1) each NR |
|
| Any respiratory, thoracic and mediastinal disorders (10038738) |
n (%) 95% CI, LL–UL |
48 (14.6) 4.0–33.6 |
32 (11.5) 3.0–27.6 |
104 (23.0) 12.9–36.0 |
184 (17.4) 12.6–23.0 |
| Rhinorrhoea (10039101) |
30 (9.1) 0.2–42.6 |
15 (5.4) 2.2–10.9 |
47 (10.4) 4.5–19.6 |
92 (8.7) 5.8–12.4 |
|
| Cough (10011224) |
12 (3.7) 1.9–6.3 |
11 (4.0) 0.4–14.7 |
48 (10.6) 3.5–23.2 |
71 (6.7) 3.5–11.4 |
|
| Nasal congestion (10028735) |
10 (3.0) 0.3–11.2 |
10 (3.6) 0.2–16.3 |
37 (8.2) 5.8–11.1 |
57 (5.4) 3.0–8.8 |
|
| Oropharyngeal pain (10068319) |
10 (3.0) 1.1–6.6 |
15 (5.4) 0.8–17.2 |
26 (5.7) 1.3–15.2 |
51 (4.8) 3.2–7.0 |
|
| Dysphonia (10013952) |
4 (1.2) 0.3–3.1 |
9 (3.2) 0.4–11.0 |
10 (2.2) 1.1–4.0 |
23 (2.2) 1.4–3.3 |
|
| Epistaxis (10015090) |
1 (0.3) 0.0–3.9 |
4 (1.4) 0.1–6.7 |
4 (0.9) 0.0–7.4 |
9 (0.9) 0.3–1.9 |
|
| Wheezing (10047924) |
1 (0.3) 0.0–5.5 |
3 (1.1) 0.0–13.1 |
2 (0.4) 0.1–1.6 |
6 (0.6) 0.1–1.5 |
|
| Dyspnoea (10013968); sneezing (10041232) |
n = 0; 1 NR |
n = 3; 0 NR |
n = 0; 2 NR |
3 (0.3) each NR |
|
| Dry throat (10013789); increased upper airway secretion (10062717); pharyngeal inflammation (10065716); throat clearing (10080125) |
n = 1; 0; 0 NR |
n = 0; 0; 0 NR |
n = 0; 1; 1 NR |
1 (0.1) each NR |
|
| Any musculoskeletal and connective tissue disorders (10028395) |
n (%) 95% CI, LL–UL |
35 (10.6) 3.6–22.9 |
23 (8.3) 1.5–23.6 |
38 (8.4) 0.3–37.2 |
96 (9.1) 5.8–13.3 |
| Myalgia (10028411) |
27 (8.2) 1.6–22.6 |
15 (5.4) 0.6–19.0 |
31 (6.8) 0.4–28.3 |
73 (6.9) 4.3–10.3 |
|
| Arthropathy (10003285) |
11 (3.3) 0.2–15.3 |
10 (3.6) 0.3–13.5 |
11 (2.4) 0.0–29.2 |
32 (3.0) 1.3–6.0 |
|
| Pain in extremity (10033425) |
0 (0.0) 0.0–1.1 |
2 (0.7) 0.1–2.6 |
1 (0.2) 0.0–2.3 |
3 (0.3) 0.1–0.8 |
|
| Rheumatic disorder (10072736) |
0 (0.0) 0.0–1.1 |
2 (0.7) 0.0–8.9 |
0 (0.0) 0.0–0.8 |
2 (0.2) 0.0–1.3 |
|
| Limb discomfort (10061224); muscle spasms (10028334); musculoskeletal pain (10028391); synovial cyst (10042858) |
n = 0; 0; 0 NR |
n = 1; 1; 0 NR |
n = 0; 0; 1 NR |
1 (0.1) each NR |
|
| Any nervous system disorders (10029205) |
n (%) 95% CI, LL–UL |
27 (8.2) 1.6–22.6 |
22 (7.9) 1.8–21.0 |
36 (8.0) 0.6–29.7 |
85 (8.0) 5.3–11.5 |
| Headache (10019211) |
24 (7.3) 1.7–19.2 |
21 (7.6) 1.3–22.4 |
33 (7.3) 1.1–22.5 |
78 (7.4) 5.1–10.2 |
|
| Dizziness (10013573) |
3 (0.9) 0.0–11.3 |
0 (0.0) 0.0–1.3 |
1 (0.2) 0.0–4.8 |
4 (0.4) 0.0–1.7 |
|
| Aphonia (10002953); poor quality sleep (10062519); somnolence (10041349); tremor (10044565) |
n = 0; 0; 0; 1 NR |
n = 0; 1; 0; 0 NR |
n = 1; 0; 1; 0 NR |
1 (0.1) each NR |
|
| Febrile convulsion (10016284) |
0 (0.0) 0.0–1.1 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
0 (0.0) 0.0–0.4 |
|
| Any gastrointestinal disorders (10017947) |
n (%) 95% CI, LL–UL |
22 (6.7) 0.1–33.1 |
14 (5.0) 0.1–25.5 |
31 (6.8) 4.1–10.7 |
67 (6.3) 4.2–9.0 |
| Diarrhoea (10012735) |
6 (1.8) 0.0–14.0 |
9 (3.2) 0.4–11.0 |
18 (4.0) 2.4–6.2 |
33 (3.1) 2.0–4.6 |
|
| Nausea (10028813) |
14 (4.3) 0.2–19.1 |
5 (1.8) 0.0–21.0 |
13 (2.9) 0.3–10.1 |
32 (3.0) 1.6–5.2 |
|
| Vomiting (10047700) |
5 (1.5) 0.3–4.8 |
0 (0.0) 0.0–1.3 |
14 (3.1) 0.4–10.9 |
19 (1.8) 0.7–3.7 |
|
| Abdominal pain (10000081) |
0 (0.0) 0.0–1.1 |
0 (0.0) 0.0–1.3 |
3 (0.7) 0.0–6.9 |
3 (0.3) 0.0–1.6 |
|
| Abdominal discomfort (10000059), gingival bleeding (10018276); lip swelling (10024570); stomatitis (10042128); tongue discomfort (10077855) |
n = 0; 0; 0; 0; 0 NR |
n = 0; 1; 1; 1; 1 NR |
n = 1; 0; 0; 0; 0 NR |
1 (0.1) each NR |
|
| Any infections and infestations (10021881) |
n (%) 95% CI, LL–UL |
15 (4.6) 0.1–25.5 |
22 (7.9) 2.2–19.1 |
29 (6.4) 0.2–29.1 |
66 (6.2) 3.5–10.1 |
| Conjunctivitis (10010741) |
12 (3.7) 0.1–19.5 |
11 (4.0) 0.6–12.4 |
13 (2.9) 0.0–22.6 |
36 (3.4) 1.6–6.2 |
|
| Rhinitis (10039083) |
6 (1.8) 0.1–8.0 |
13 (4.7) 0.6–15.4 |
13 (2.9) 0.1–15.2 |
32 (3.0) 1.5–5.3 |
|
| Bronchitis (10006451); ear infection (10014011); herpes simplex (10019948); hordeolum (10020377); laryngitis (10023874); nasopharyngitis (10028810), oral herpes (10067152); upper respiratory tract infection (10046306) |
n = 0; 0; 0; 0; 0; 0; 0; 0 NR |
n = 0; 0; 1; 0; 0; 0; 1; 0 NR |
n = 1; 1; 0; 1; 1; 1; 0; 1 NR |
1 (0.1) each NR |
|
| Any metabolism and nutrition disorders (10027433) |
n (%) 95% CI, LL–UL |
7 (2.1) 0.1–9.8 |
1 (0.4) 0.0–7.2 |
24 (5.3) 0.3–22.7 |
32 (3.0) 0.8–7.6 |
| Decreased appetite (10061428) |
7 (2.1) 0.1–9.8 |
1 (0.4) 0.0–7.2 |
24 (5.3) 0.3–22.7 |
32 (3.0) 0.8–7.6 |
|
| Any psychiatric disorders (10037175) |
n (%) 95% CI, LL–UL |
3 (0.9) 0.0–7.2 |
5 (1.8) 0.0–21.0 |
11 (2.4) 0.4–7.6 |
19 (1.8) 0.8–3.5 |
| Irritability (10022998) |
3 (0.9) 0.0–7.2 |
4 (1.4) 0.0–17.1 |
11 (2.4) 0.4–7.6 |
18 (1.7) 0.7–3.3 |
|
| Insomnia (10022437); mood swings (10027951); sleep disorder (10040984) |
n = 0; 0; 0 NR |
n = 1; 0; 1 NR |
n = 0; 1; 0 NR |
1 (0.1) each NR |
|
| Any skin and subcutaneous tissue disorders (10040785) |
n (%) 95% CI, LL–UL |
6 (1.8) 0.0–15.6 |
6 (2.2) 0.3–7.4 |
6 (1.3) 0.0–11.5 |
18 (1.7) 0.7–3.4 |
| Pruritus (10037087) |
3 (0.9) 0.0–7.2 |
5 (1.8) 0.0–10.2 |
0 (0.0) 0.0–0.8 |
8 (0.8) 0.1–2.4 |
|
| Rash (10037844) |
1 (0.3) 0.0–3.9 |
1 (0.4) 0.0–7.2 |
4 (0.9) 0.0–7.8 |
6 (0.6) 0.2–1.4 |
|
| Erythema (10015150), pruritus generalized (10052576) | 0; 2 | 0; 0 | 2; 0 | 2 (0.2) each | |
| Rash generalized (10037858) |
0 (0.0) 0.0–1.1 |
1 (0.4) 0.0–4.5 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
|
| Hyperhidrosis (10020642) |
1 (0.3) 0.0–3.9 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.6 |
|
| Any ear and labyrinth disorders (10013993) |
n (%) 95% CI, LL–UL |
1 (0.3) 0.0–9.8 |
5 (1.8) 0.0–10.2 |
1 (0.2) 0.0–2.3 |
7 (0.7) 0.1–2.2 |
| Ear pain (10014020); vertigo (10047340) |
n = 0; 0 NR |
n = 1; 2 NR |
n = 1; 0 NR |
2 (0.2) each NR |
|
| Ear haemorrhage (10014009); ear pruritus (10052138); tinnitus (10043882) |
n = 0; 1; 0 NR |
n = 1; 0; 1 NR |
n = 0; 0; 0 NR |
1 (0.1) each NR |
|
| Any immune system disorders (10021428) |
n (%) 95% CI, LL–UL |
1 (0.3) 0.0–3.9 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.6 |
| Hypersensitivity (10020751) |
1 (0.3) 0.0–3.9 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.6 |
|
| Anaphylactic reaction (10002198) |
0 (0.0) 0.0–1.1 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
0 (0.0) 0.0–0.4 |
|
| Any investigations (10022891) |
n (%) 95% CI, LL–UL |
1 (0.3) 0.0–3.9 |
3 (1.1) 0.0–13.1 |
0 (0.0) 0.0–0.8 |
4 (0.4) 0.0–1.8 |
| Heart rate increased (10019303) |
1 (0.3) 0.0–3.9 |
3 (1.1) 0.0–13.1 |
0 (0.0) 0.0–0.8 |
4 (0.4) 0.0–1.8 |
|
| Any eye disorders (10015919) |
n (%) 95% CI, LL–UL |
1 (0.3) 0.0–9.8 |
3 (1.1) 0.1–3.7 |
0 (0.0) 0.0–0.8 |
4 (0.4) 0.0–1.4 |
| Eye discharge (10015915), eye pruritus (10052140); lacrimation increased (10023644); swelling of eyelid (10042690) |
n = 0; 0; 0; 1 NR |
n = 1; 1; 1; 0 NR |
n = 0; 0; 0; 0 NR |
1 (0.1) each NR |
|
| Any injury, poisoning and procedural complications (10022117) |
n (%) 95% CI, LL–UL |
0 (0.0) 0.0–1.1 |
1 (0.4) 0.0–4.5 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
| Muscle strain (10050031) |
0 (0.0) 0.0–1.1 |
1 (0.4) 0.0–4.5 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
|
| Any cardiac disorders (10007541) |
n (%) 95% CI, LL–UL |
0 (0.0) 0.0–1.1 |
1 (0.4) 0.0–7.2 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
| Tachycardia (10043071) |
0 (0.0) 0.0–1.1 |
1 (0.4) 0.0–7.2 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
|
| Any vascular disorders (10047065) |
n (%) 95% CI, LL–UL |
1 (0.3) 0.0–5.5 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
| Hot flush (10060800) |
1 (0.3) 0.0–5.5 |
0 (0.0) 0.0–1.3 |
0 (0.0) 0.0–0.8 |
1 (0.1) 0.0–0.7 |
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
NR: AEs that occurred in three or fewer cases were grouped to simplify the table, with the number of cases presented for each symptom and the total number (%) for each symptom, but not each individual 95% CI
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, NR not reported