Table 4. Overall incidence of TEAEs and treatment-related TEAEs, and TEAEs for which there was a statistically significant difference among treatment groupsa (safety population).
| MedDRA system organ class | Number (%) of subjects b (95% confidence interval) |
P value c | ||||
|---|---|---|---|---|---|---|
| Preferred term | IC43 100 µg (n = 33) |
IC43 100 µg w/o (n = 32) |
IC43 200 µg (n = 33) |
IC43 50 µg (n = 32) |
Placebo (n = 33) |
|
| Subjects with ≥ 1 TEAE | 32 (97) (85, 100) |
30 (94) (80, 98) |
29 (88) (73, 95) |
30 (94) (80, 98) |
26 (79) (62, 89) |
0.1448 |
| Subjects with ≥ 1 treatment-related TEAE | 29 (88) (73, 95) |
21 (66) (48, 80) |
28 (85) (69, 93) |
26 (81) (65, 91) |
10 (30) (17, 47) |
<0.0001* |
| General disorders and administration site conditions | 26 (79) (62, 89) |
20 (63) (45, 77) |
27 (82) (66, 91) |
25 (78) (61, 89) |
9 (27) (15, 44) |
<0.0001* |
| Injection site pain | 19 (58) (41, 73) |
15 (47) (31, 64) |
21 (64) (47, 78) |
21 (66) (48, 80) |
1 (3) (1, 15) |
<0.0001* |
| Injection site induration | 4 (12) (5, 27) |
1 (3) (1, 16) |
8 (24) (13, 41) |
2 (6) (2, 20) |
1 (3) (1, 15) |
0.0308* |
| Infections and infestations | 20 (61) (44, 75) |
20 (63) (45, 77) |
17 (52) (35, 68) |
13 (41) (26, 58) |
17 (52) (35, 68) |
0.4174 |
| Bronchitis | 4 (12) (5, 27) |
0 (0) (0, 11) |
2 (6) (2, 20) |
0 (0) (0, 11) |
0 (0) (0, 10) |
0.0232* |
| Musculo-skeletal and connective tissue disorders | 20 (61) (44, 75) |
9 (28) (16, 45) |
14 (42) (27, 59) |
14 (44) (28, 61) |
4 (12) (5, 27) |
0.0006* |
| Myalgia | 8 (24) (13, 41) |
5 (16) (7, 32) |
9 (27) (15, 44) |
9 (28) (16, 45) |
1 (3) (1, 15) |
0.0292* |
| Pain in extremity | 7 (21) (11, 38) |
0 (0) (0, 11) |
4 (12) (5, 27) |
4 (13) (5, 28) |
1 (3) (1, 15) |
0.0209* |
| Injury, poisoning and procedural complications | 1 (3) (1, 15) |
3 (9) (3, 24) |
4 (12) (5, 27) |
3 (9) (3, 24) |
3 (9) (3, 24) |
0.7666 |
| Joint sprain | 0 (0) (0, 10) |
0 (0) (0, 11) |
3 (9) (3, 24) |
0 (0) (0, 11) |
0 (0) (0, 10) |
0.0371* |
| Surgical and medical procedures | 0 (0) (0, 10) |
1 (3) (1, 16) |
1 (3) (1, 15) |
4 (13) (5, 28) |
0 (0) (0, 10) |
0.0445* |
a MedDRA preferred terms are included if there was a statistically significant difference among treatment groups, together with the corresponding MedDRA system organ class. Additionally, MedDRA system organ classes are provided on their own if there was a statistically significant difference among treatment groups. bSubjects are counted only once per system organ class or preferred term. Percentages and confidence intervals are based on the number (n) in each group and rounded to nearest integer. cP values were calculated according to Fisher”Freeman”Halton test. Two-sided 95% confidence intervals were calculated according Altman.17 *Statistically significant difference among treatment groups. MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event; w/o, without adjuvant.