| Center | First participant in | Months accruing | Participants accrued | Accrual rate (per month) | |
|---|---|---|---|---|---|
| 2 | Lausanne | 07Jan2025 | 6 | 43 | 7.41 |
| 3 | Chur | 01Jan2025 | 6 | 34 | 5.67 |
| 4 | Luzern | 05Jan2025 | 6 | 37 | 6.31 |
| 5 | Neuchâtel | 02Jan2025 | 6 | 36 | 6.03 |
| 6 | Fribourg | 11Jan2025 | 6 | 29 | 5.12 |
| 7 | Baden | 03Jan2025 | 6 | 25 | 4.21 |
| 8 | Aarau | 01Jan2025 | 6 | 43 | 7.17 |
| 9 | Bern | 07Jan2025 | 6 | 37 | 6.38 |
| 10 | Olten | 01Jan2025 | 6 | 32 | 5.33 |
| 11 | Sion | 06Jan2025 | 6 | 26 | 4.46 |
| 12 | Basel | 07Jan2025 | 6 | 30 | 5.17 |
| 13 | Berlin | 23Jan2025 | 5 | 10 | 1.90 |
| 14 | Verona | 18Jan2025 | 5 | 15 | 2.76 |
| 15 | Zurich | 07Jan2025 | 6 | 41 | 7.07 |
| 16 | Lugano | 04Jan2025 | 6 | 29 | 4.92 |
| 17 | St. Gallen | 01Jan2025 | 6 | 37 | 6.17 |
| 18 | Solothurn | 03Jan2025 | 6 | 25 | 4.21 |
| 19 | Paris | 07Feb2025 | 5 | 4 | 0.84 |
| 20 | Amiens | 25Jan2025 | 5 | 13 | 2.50 |
| 21 | Bellinzona | 08Jan2025 | 6 | 31 | 5.38 |
| 22 | Geneva | 04Jan2025 | 6 | 23 | 3.90 |
| 23 | Overall | 01Jan2025 | 6 | 600 | 100.00 |
| Center | First participant in | Months accruing | Participants accrued | Accrual rate (per month) | |
|---|---|---|---|---|---|
| 2 | Switzerland | 01.01.2025 | 6 | 558 | 93.00 |
| 3 | Germany | 23.01.2025 | 5 | 10 | 1.90 |
| 4 | Italy | 18.01.2025 | 5 | 15 | 2.76 |
| 5 | France | 25.01.2025 | 5 | 17 | 3.27 |
| 6 | Overall | 01.01.2025 | 6 | 600 | 100.00 |
So far 58 patients had at least one SAE since the start of the study. This represents 10% of patients.
| Country | Patients with ≥1 SAE |
Total Patients |
% with SAE |
|---|---|---|---|
| France | 3 | 17 | 17.6 |
| Germany | 1 | 10 | 10.0 |
| Switzerland | 53 | 558 | 9.5 |
| Italy | 1 | 15 | 6.7 |
| Event Name | Disability | Hospitalization | Life-threatening | Other |
|---|---|---|---|---|
| Bone fracture | 1 | 7 | 1 | 4 |
| Cardiovascular event | 1 | 8 | 1 | 2 |
| Genital infection | 0 | 6 | 1 | 3 |
| Gout attack | 1 | 9 | 2 | 4 |
| Ketoacidosis | 0 | 5 | 0 | 2 |
| New onset diabetes mellitus | 3 | 8 | 0 | 1 |
| Urinary tract infection | 1 | 4 | 5 | 0 |
| Country | Total Patients | Dropouts | % Dropouts |
|---|---|---|---|
| France | 17 | 3 | 17.6 |
| Switzerland | 558 | 64 | 11.5 |
| Germany | 10 | 1 | 10.0 |
| Italy | 15 | 0 | 0.0 |
| Reason | Count | % of All Dropouts |
|---|---|---|
| Adverse event | 22 | 32.4 |
| Withdrawal of consent | 17 | 25.0 |
| Lost to follow-up | 16 | 23.5 |
| Investigator decision | 7 | 10.3 |
| Protocol deviation | 4 | 5.9 |
| Death | 2 | 2.9 |
| Form | Missing (%) |
|---|---|
| Labs | 34.5 |
| AE | 29.3 |
| Vitals | 24.2 |
| ConMeds | 19.9 |
| Demographics | 14.6 |