Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-103 · 3 trials · 2 indications
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.
Change in 6-minute walk distance
| Arm | Type | Description |
|---|---|---|
| TNX-103 | EXPERIMENTAL | Open-label oral levosimendan 1-3mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (oral) |
| Name | Type | Description |
|---|---|---|
| TNX-103 | DRUG | Open-label oral levosimendan 1-3mg |
| Placebo | DRUG | Matching placebo (oral) |
Inclusion Criteria: * Completed a TNX-103 parent study * Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103 * Requirements related to childbearing potential, contraception, and egg/sperm donation Exclusion Criteria: * Investigator or Sponsor op...