. 2022 Mar 16;186(6):687–700. doi: 10.1530/EJE-21-0972
This work is licensed under a Table 4.
Adverse events in the safety population of a randomised clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity by System Organ Class and Preferred Medical Term. Data presented as no. patients with event (% of patients) no. events for each treatment group in the safety population. The number of patients in each subgroup was too small to perform inferential tests.
| Tesomet (n = 14) | Placebo (n =8) | |||
|---|---|---|---|---|
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| All adverse events | 12 (86%) | 64 | 7 (88%) | 34 |
| Serious adverse events | 2 (14%) | 3 | 1 (13%) | 1 |
| Treatment discontinuation adverse events | 1 (7%) | 2 | 1 (13%) | 1 |
| Severity of adverse events | ||||
| Mild | 11 (79%) | 36 | 7 (88%) | 14 |
| Moderate | 10 (71%) | 23 | 5 (63%) | 17 |
| Severe | 2 (14%) | 5 | 2 (25%) | 3 |
| Gastrointestinal disorders | 9 (64%) | 17 | 5 (63%) | 12 |
| Abdominal pain, upper | 3 (21%) | 3 | 3 (38%) | 5 |
| Dry mouth | 6 (43%) | 6 | 0 | |
| Nausea | 2 (14%) | 3 | 2 (25%) | 2 |
| Vomiting | 1 (7%) | 1 | 2 (25%) | 2 |
| Constipation | 2 (14%) | 2 | 0 | |
| Diarrhoea | 0 | 2 (25%) | 2 | |
| Faeces hard | 2 (14%) | 2 | 0 | |
| Gastroesophageal reflux disorders | 0 | 1 (13%) | 1 | |
| Nervous system disorders | 8 (57%) | 16 | 3 (38%) | 6 |
| Dizziness | 6 (43%) | 9 | 3 (38%) | 6 |
| Headache | 5 (36%) | 6 | 0 | |
| Presyncope | 1 (7%) | 1 | 0 | |
| Psychiatric disorders | 7 (50%) | 9 | 1 (13%) | 1 |
| Sleep disorders | 7 (50%) | 7 | 1 (13%) | 1 |
| Anxiety* | 1 (7%) | 1 | 0 | |
| Paranoia* | 1 (7%) | 1 | 0 | |
| Musculoskeletal and connective tissue disorders | 3 (21%) | 3 | 2 (25%) | 2 |
| Muscle spasms | 1 (7%) | 1 | 0 | |
| Musculoskeletal pain | 1 (7%) | 1 | 0 | |
| Myalgia | 0 | 1 (13%) | 1 | |
| Neck pain | 1 (7%) | 1 | 0 | |
| Pain in extremity | 0 | 1 (13%) | 1 | |
| Skin and s.c. tissue disorders | 3 (21%) | 3 | 1 (13%) | 1 |
| Hyperhidrosis | 3 (21%) | 3 | 0 | |
| Night sweats | 0 | 1 (13%) | 1 | |
| General disorders and administration site conditions | 2 (14%) | 2 | 2 (25%) | 2 |
| Fatigue | 1 (7%) | 1 | 1 (13%) | 1 |
| Pyrexia | 0 | 1 (13%) | 1 | |
| Energy increased | 1 (7%) | 1 | 0 | |
| Cardiac disorders | 0 | 1 (13%) | 1 | |
| Palpitations | 0 | 1 (13%) | 1 | |
| Metabolism and nutritional disorders | 0 | 1 (13%) | 1 | |
| Hyponatremia | 0 | 1 (13%) | 1 | |
| Investigational | 1 (7%) | 1 | 0 | |
| Blood pressure increased | 1 (7%) | 1 | 0 | |
| Neoplasms | 1 (7%) | 1 | 0 | |
| Craniopharyngioma | 1 (7%) | 1 | 0 | |
| Injury, poisoning and procedural complications | 1 (7%) | 1 | 1 (13%) | 1 |
| Fall | 0 | 1 (13%) | 1 | |
| Post-procedural complications | 1 (7%) | 1 | 0 | |
| Hepatobiliary disorders | 0 | 1 (13%) | 1 | |
| Cholecystitis | 0 | 1 (13%) | 1 | |
| Respiratory, thoracic and mediastinal disorders | 2 (14%) | 3 | 1 (13%) | 1 |
| Cough | 0 | 1 (13%) | 1 | |
| Rhinorrhoea | 1 (7%) | 2 | 0 | |
| Viral upper respiratory tract infection | 1 (7%) | 1 | 0 | |
| Infections and infestations | 6 (43%) | 8 | 3 (38%) | 5 |
| Gastroenteritis | 1 (7%) | 1 | 1 (13%) | 1 |
| Viral tonsillitis | 0 | 2 (25%) | 2 | |
| Viral upper respiratory tract infection | 2 (14%) | 2 | 0 | |
| Upper respiratory tract infection | 1 (7%) | 1 | 0 | |
| Eye infection | 1 (7%) | 1 | 0 | |
| Gastroenteritis viral | 0 | 1 (13%) | 1 | |
| Gingivitis | 1 (7%) | 1 | 0 | |
| Tonsillitis | 1 (7%) | 1 | 0 | |
| Influenza | 0 | 1 (13%) | 1 | |
| Sinusitis | 1 (7%) | 1 | 0 | |
*One patient developed both anxiety and paranoia.