Table 2 |.
Treatment-emergent AEs though system organ class/preferred term through 8 d
| ShA9 (n = 3) n (%) (count) | Vehicle (n = 18) n (%) (count) | Total (n = 54) n (%) (count) | Risk difference (95% Cl)a | P valuea | |
|---|---|---|---|---|---|
| Any AE | 20 (55.6) (63) | 15 (83.3) (55) | 35 (64.8) (118) | −0.28 (−0.514, −0.041) | 0.044 |
| Skin and subcutaneous tissue disorders | 14 (38.9) (24) | 11 (61.1) (24) | 25 (46.3) (48) | −0.22 (−0.498, 0.054) | 0.123 |
| Eczemab | 14 (38.9) (24) | 10 (55.6) (22) | 24 (44.4) (46) | −0.17 (−0.446, 0.113) | 0.245 |
| Pruritus | 0 (0.0) (0) | 1 (5.6) (2) | 1 (1.9) (2) | −0.06 (−0.274, 0.054) | 0.333 |
| Musculoskeletal and connective tissue disorders | 12 (33.3) (21) | 7 (38.9) (18) | 19 (35.2) (39) | −0.06 (−0.328, 0.217) | 0.687 |
| Pain in extremityb | 12 (33.3) (21) | 7 (38.9) (18) | 19 (35.2) (39) | −0.06 (−0.328, 0.217) | 0.687 |
| General disorders and administration site conditions | 9 (25.0) (15) | 4 (22.2) (11) | 13 (24.1) (26) | 0.03 (−0.245, 0.255) | >0.999 |
| Peripheral swellingb | 8 (22.2) (14) | 4 (22.2) (11) | 12 (22.2) (25) | 0.00 (−0.274, 0.224) | >0.999 |
| Chillsb | 1 (2.8) (1) | 0 (0.0) (0) | 1 (1.9) (1) | 0.03 (−0.162, 0.150) | >0.999 |
| Gastrointestinal disorders | 2 (5.6) (2) | 1 (5.6) (1) | 3 (5.6) (3) | 0.00 (−0.220, 0.149) | >0.999 |
| Abdominal pain upper | 1 (2.8) (1) | 1 (5.6) (1) | 2 (3.7) (2) | −0.03 (−0.245, 0.112) | >0.999 |
| Abdominal discomfort | 1 (2.8) (1) | 0 (0.0) (0) | 1 (1.9) (1) | 0.03 (−0.162, 0.150) | >0.999 |
| Infections and infestations | 1 (2.8) (1) | 0 (0.0) (0) | 1 (1.9) (1) | 0.03 (−0.162, 0.150) | >0.999 |
| Furuncle | 1 (2.8) (1) | 0 (0.0) (0) | 1 (1.9) (1) | 0.03 (−0.162, 0.150) | >0.999 |
| Reproductive system and breast disorders | 0 (0.0) (0) | 1 (5.6) (1) | 1 (1.9) (1) | −0.06 (−0.274, 0.054) | 0.333 |
| Dysmenorrhea | 0 (0.0) (0) | 1 (5.6) (1) | 1 (1.9) (1) | −0.06 (−0.274, 0.054) | 0.333 |
Note: at each level of summarization, subjects reporting more than one AE are only counted once. Note: incidences are displayed in descending order of frequency of system organ class and by descending order of frequency of preferred term within system organ class. Note: system organ class/preferred term is based on v.20.0 of the MedDRA coding dictionary.
95% exact unconditional CIs (based on the Santner and Snell method); P values are based on the chi-squared test (if expected cell counts are all >5) or the two-sided Fisher's exact test. n, number of subjects reporting at least one AE with system organ class/preferred term. %, percentage of subjects among treatment group; count, count of AEs within system prgan class/preferred term.
Symptom based on subjective daily diary reporting by participants.