Table 3.
Adverse Events Reported by System Organ Class and Preferred Term with an Incidence of 3% of Participants or Greater in All Treatment Groups, Safety Population.*
| System Organ Class and Preferred Term | Placebo (n=56) |
Mid-Dose PHEN/TPM (n=54) |
Top-Dose PHEN/TPM (n=113) |
Overall (N=223) |
|---|---|---|---|---|
| Any treatment-emergent adverse event | 29 (51.8) | 20 (37.0) | 59 (52.2) | 108 (48.4) |
| Infections and infestations | 15 (26.8) | 9 (16.7) | 25 (22.1) | 49 (22.0) |
| Covid-19 | 4 (7.1) | 2 (3.7) | 4 (3.5) | 10 (4.5) |
| Upper respiratory tract infection | 4 (7.1) | 1 (1.9) | 4 (3.5) | 9 (4.0) |
| Nasopharyngitis | 3 (5.4) | 1 (1.9) | 2 (1.8) | 6 (2.7) |
| Gastroenteritis viral | 2 (3.6) | 1 (1.9) | 1 (0.9) | 4 (1.8) |
| Influenza | 0 | 2 (3.7) | 2 (1.8) | 4 (1.8) |
| Nervous system disorders | 7 (12.5) | 5 (9.3) | 16 (14.2) | 28 (12.6) |
| Headache | 5 (8.9) | 4 (7.4) | 5 (4.4) | 14 (6.3) |
| Dizziness | 0 | 1 (1.9) | 4 (3.5) | 5 (2.2) |
| Gastrointestinal disorders | 8 (14.3) | 7 (13.0) | 12 (10.6) | 27 (12.1) |
| Abdominal pain | 2 (3.6) | 0 | 0 | 2 (0.9) |
| Nausea | 2 (3.6) | 2 (3.7) | 5 (4.4) | 9 (4.0) |
| Respiratory, thoracic and mediastinal disorders | 7 (12.5) | 4 (7.4) | 13 (11.5) | 24 (10.8) |
| Nasal congestion | 4 (7.1) | 3 (5.6) | 3 (2.7) | 10 (4.5) |
| Oropharyngeal pain | 2 (3.6) | 0 | 3 (2.7) | 5 (2.2) |
| General disorders and administration site conditions | 3 (5.4) | 2 (3.7) | 13 (11.5) | 18 (8.1) |
| Pyrexia | 1 (1.8) | 1 (1.9) | 5 (4.4) | 7 (3.1) |
| Injury, poisoning, and procedural complications | 5 (8.9) | 5 (9.3) | 7 (6.2) | 17 (7.6) |
| Ligament sprain | 0 | 2 (3.7) | 2 (1.8) | 4 (1.8) |
| Psychiatric disorders | 1 (1.8) | 4 (7.4) | 10 (8.8) | 15 (6.7) |
| Depression | 0 | 1 (1.9) | 5 (4.4) | 6 (2.7) |
| Musculoskeletal and connective tissue disorders | 1 (1.8) | 4 (7.4) | 10 (8.8) | 15 (6.7) |
| Arthralgia | 0 | 1 (1.9) | 4 (3.5) | 5 (2.2) |
| Back pain | 2 (3.6) | 0 | 2 (1.8) | 4 (1.8) |
| Vascular disorders | 2 (3.6) | 0 | 2 (1.8) | 4 (1.8) |
| Hypertension | 2 (3.6) | 0 | 2 (1.8) | 4 (1.8) |
*
Data are no. (%). The mid and top doses are 7.5 mg/46 mg and 15 mg/92 mg of phentermine/topiramate (PHEN/TPM), respectively. The denominator for percentages is the number of participants in the safety population. The MedDRA Dictionary (version 23.1) was used for coding. If a participant experienced more than one episode of an adverse event, the participant was counted only once within a preferred term. If a participant experienced more than one adverse event within a system organ class, the participant was counted once for each preferred term and once for the system organ class.