TABLE 3.
All adverse events with frequency of ≥5% in any PHEN/TPM CR group1
| Standardized lifestyle intervention across all treatment groups |
||||||
| Weeks 0–56 |
Weeks 56–108 |
|||||
| PHEN/TPM CR |
PHEN/TPM CR |
|||||
| Placebo(n = 227) | 7.5/46(n = 153) | 15/92(n = 295) | Placebo(n = 227) | 7.5/46(n = 153) | 15/92(n = 295) | |
| n (%) | n (%) | |||||
| Constipation | 16 (7.1) | 25 (16.3) | 62 (21.0) | 7 (3.1) | 11 (7.2) | 12 (4.1) |
| Paraesthesia | 6 (2.6) | 21 (13.7) | 62 (21.0) | 0 (0.0) | 1 (0.7) | 10 (3.4) |
| Dry mouth | 5 (2.2) | 21 (13.7) | 59 (20.0) | 1 (0.4) | 1 (0.7) | 4 (1.4) |
| Upper respiratory tract infection | 47 (20.7) | 23 (15.0) | 55 (18.6) | 42 (18.5) | 26 (17.0) | 45 (15.3) |
| Nasopharyngitis | 35 (15.4) | 20 (13.1) | 39 (13.2) | 26 (11.5) | 13 (8.5) | 26 (8.8) |
| Dysgeusia | 4 (1.8) | 18 (11.8) | 39 (13.2) | 0 (0.0) | 1 (0.7) | 3 (1.0) |
| Sinusitis | 19 (8.4) | 17 (11.1) | 39 (13.2) | 18 (7.9) | 12 (7.8) | 28 (9.5) |
| Headache | 21 (9.3) | 8 (5.2) | 28 (9.5) | 6 (2.6) | 4 (2.6) | 12 (4.1) |
| Insomnia | 15 (6.6) | 12 (7.8) | 24 (8.1) | 8 (3.5) | 9 (5.9) | 11 (3.7) |
| Diarrhea | 12 (5.3) | 14 (9.2) | 21 (7.1) | 3 (1.3) | 3 (2.0) | 11 (3.7) |
| Back pain | 19 (8.4) | 11 (7.2) | 21 (7.1) | 7 (3.1) | 9 (5.9) | 15 (5.1) |
| Dizziness | 6 (2.6) | 9 (5.9) | 20 (6.8) | 2 (0.9) | 2 (1.3) | 1 (0.3) |
| Nausea | 13 (5.7) | 5 (3.3) | 19 (6.4) | 4 (1.8) | 10 (6.5) | 4 (1.4) |
| Bronchitis | 8 (3.5) | 9 (5.9) | 17 (5.8) | 7 (3.1) | 8 (5.2) | 10 (3.4) |
| Fatigue | 11 (4.9) | 7 (4.6) | 17 (5.8) | 2 (0.9) | 2 (1.3) | 4 (1.4) |
| Procedural pain | 6 (2.6) | 7 (4.6) | 17 (5.8) | 4 (1.8) | 8 (5.2) | 14 (4.7) |
| Arthralgia | 20 (8.8) | 13 (8.5) | 13 (4.4) | 14 (6.2) | 7 (4.6) | 16 (5.4) |
| Influenza | 11 (4.9) | 11 (7.2) | 13 (4.4) | 8 (3.5) | 10 (6.5) | 19 (6.4) |
| Urinary tract infection | 11 (4.9) | 8 (5.2) | 13 (4.4) | 13 (5.7) | 14 (9.2) | 18 (6.1) |
| Gastroenteritis | 12 (5.3) | 3 (2.0) | 12 (4.1) | 6 (2.6) | 2 (1.3) | 9 (3.1) |
1
Preferred terms were defined by the MedDRA Coding Dictionary, version 10.1 (26). PHEN/TPM CR, controlled-release phentermine/topiramate; 7.5/46, 7.5 mg phentermine/46 mg controlled-release topiramate; 15/92, 15 mg phentermine/92 mg controlled-release topiramate.