Table 3.
Summary of Treatment Emergent Adverse Events
| All (n=62) | Female (n=23) | Male (n=39) | |||||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| TEAE, n (%) | Buspirone (n=35) | Placebo (n=27) | P Valuea | Buspirone (n=11) | Placebo (n=12) | P Valuea | Buspirone (n=24) | Placebo (n=15) | P Valuea |
| Any TEAEsb | 33 (94.3) | 21 (77.8) | 0.0689 | 11 (100.0) | 11 (91.7) | 1.0000 | 22 (91.7) | 10 (66.7) | 0.0846 |
| TEAEs related to study medicationc | 22 (62.9) | 8 (29.6) | 0.0094 | 9 (81.8) | 4 (33.3) | 0.0361 | 13 (54.2) | 4(26.7) | 0.0920 |
| Any serious TEAE | 3 (8.6) | 0 (0.0) | 0.2504 | 1 (9.1) | 0 (0.0) | 0.4783 | 2 (8.3) | 0 (0.0) | 0.5142 |
| Discontinued medication due to TEAEs | 0 (0.0) | 0 (0.0) | -- | 0 (0.0) | 0 (0.0) | -- | 0 (0.0) | 0 (0.0) | -- |
| Most frequent TEAEs d by MedDRA®e preferred term | |||||||||
| Nervous system disorders | |||||||||
| Dizziness | 15 (42.9) | 1 (3.7) | 0.0005 | 6 (54.5) | 0 (0.0) | 0.0046 | 9 (37.5) | 1 (6.7) | 0.0574 |
| Somnolence | 3 (8.6) | 2 (7.4) | 1.0000 | 2 (18.2) | 1 (8.3) | 0.5901 | 1 (4.2) | 1 (6.7) | 1.0000 |
| Infections and infestations | |||||||||
| Nasopharyngitis | 8 (22.9) | 4 (14.8) | 0.4268 | 1 (9.1) | 1 (8.3) | 1.0000 | 7 (29.2) | 3 (20.0) | 0.7110 |
| Bronchitis | 2 (5.7) | 1 (3.7) | 1.0000 | 1 (9.1) | 0 (0.0) | 0.4783 | 1 (4.2) | 1 (6.7) | 1.0000 |
| Influenza | 3 (8.6) | 0 (0.0) | 0.2504 | 2 (18.2) | 0 (0.0) | 0.2174 | 1 (4.2) | 0 (0.0) | 1.0000 |
| Gastrointestinal disorders | |||||||||
| Nausea | 8 (22.9) | 2 (7.4) | 0.1642 | 3 (27.3) | 2 (16.7) | 0.6404 | 5 (20.8) | 0 (0.0) | 0.1359 |
| Diarrhea | 2 (5.7) | 1 (3.7) | 1.0000 | 0 (0.0) | 1 (8.3) | 1.0000 | 2 (8.3) | 0 (0.0) | 0.5142 |
| Dyspepsia | 2 (5.7) | 1 (3.7) | 1.0000 | 2 (18.2) | 0 (0.0) | 0.2174 | 0 (0.0) | 1 (6.7) | 0.3846 |
| Musculoskeletal and connective tissue disorders | |||||||||
| Back pain | 5 (14.3) | 2 (7.4) | 0.4550 | 2 (18.2) | 2 (16.7) | 1.0000 | 3 (12.5) | 0 (0.0) | 0.2713 |
| Arthralgia | 2 (5.7) | 1 (3.7) | 1.0000 | 1 (9.1) | 0 (0.0) | 0.4783 | 1 (4.2) | 1 (6.7) | 1.0000 |
| Pain in Extremity | 2 (5.7) | 1 (3.7) | 1.0000 | 1 (9.1) | 1 (8.3) | 1.0000 | 1 (4.2) | 0 (0.0) | 1.0000 |
| Respiratory, thoracic and mediastinal disorders | |||||||||
| Pulmonary congestion | 2 (5.7) | 0 (0.0) | 0.5003 | 1 (9.1) | 0 (0.0) | 0.4783 | 1 (4.2) | 0 (0.0) | 1.0000 |
| Sinus congestion | 2 (5.7) | 0 (0.0) | 0.5003 | 0 (0.0) | 0 (0.0) | -- | 2 (8.3) | 0 (0.0) | 0.5142 |
| Weight increased | 2 (5.7) | 1 (3.7) | 1.0000 | 2 (18.2) | 1 (8.3) | 0.5901 | 0 (0.0) | 0 (0.0) | -- |
| Insomnia | 2 (5.7) | 0 (0.0) | 0.5003 | 0 (0.0) | 0 (0.0) | -- | 2 (8.3) | 0 (0.0) | 0.5142 |
Note. TEAE = Treatment Emergent Adverse Event;
P values are from either Fisher’s exact test or Pearson chi-square, depending on marginal frequency counts.
TEAEs are adverse events defined as a new illness, or an exacerbation of a pre-existing condition, occurring between the first dose of study drug and one week after the last dose of study drug;
TEAE rated as possibly, probably or definitely related to treatment;
TEAEs presented here were reported by >5% of buspirone group and at a greater rate than by the placebo group, in the full sample (n=62);
MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).