Table 3.
Adverse events experienced by more than 10% of participants, coded according to preferred terma
| Study Part 1 | Study Part 2 | |||||
| Dantrium® 60 mg (N = 16) | NPJ5008 60 mg (N = 16) | NPJ5008 120 mg (N = 5) | ||||
| Adverse event (AE) | n (%) | Total number of events | n (%) | Total number of events | n (%) | Total number of events |
| AEb (TEAE) | 15 (93.8) | 49 | 16 (100) | 61 | 5 (100) | 35 |
| Serious TEAE | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe TEAE | 0 | 0 | 0 | 0 | 1 (20) | 1c (one muscular weakness event) |
| Moderate TEAE | 1 (6.3) | 1c (one muscular weakness) | 2 (12.5) | 3c (one headache; two muscular weakness) | 3 (60) | 5c (two muscular weakness; three dizziness) |
| Adverse drug reactionsd (ADR) | 15 (93.8) | 45 | 16 (100) | 56 | 5 (100) | 35 |
| Dizziness | 14 (87.5) | 14 | 14 (87.5) | 14 | 5 (100) | 8 |
| Muscular weakness | 9 (56.3) | 9 | 8 (50.0) | 8 | 5 (100) | 8 |
| Dysarthria | 6 (37.5) | 6 | 6 (37.5) | 6 | 5 (100) | 5 |
| Blurred vision | 6 (37.5) | 7 | 9 (56.3) | 10 | 4 (80) | 4 |
| Dyspnoea | 2 (12.5) | 2 | 3 (18.8) | 3 | 2 (40) | 2 |
| Somnolence | 2 (12.5) | 2 | 1 (6.3) | 1 | 1 (20) | 1 |
| Headache | 0 | 0 | 2 (12.5) | 3 | 1 (20) | 1 |
| Dysphagia | 0 | 0 | 0 | 0 | 3 (60) | 3 |
| Balance disorder | 0 | 0 | 2 (12.5) | 2 | 0 | 0 |
| Infusion site discomfort | 1 (6.3) | 1 | 1 (6.3) | 1 | 0 | 0 |
| Nausea | 0 | 0 | 1 (6.3) | 1 | 1 (20) | 1 |
| Flushing | 0 | 0 | 2 (12.5) | 2 | 0 | 0 |
| Dysphonia | 0 | 0 | 0 | 0 | 1 (20) | 1 |
Mild adverse events of catheter site-related reactions, flatulence, abdominal discomfort and feeling cold were considered unrelated to the study drugs. N is the total number of participants in the group, n is the number of participants reporting at least one event, % is percentage of total participants in group.
A TEAE was any untoward medical occurrence in a participant that occurred either before dosing (referred to as a predose adverse event) or once a medicinal product had been administered, including occurrences that were not necessarily caused by or related to that product.
All moderate or severe adverse events were considered related to the study drugs (i.e. ADRs) apart from one moderate adverse event of headache that was considered unrelated to the test drug. Counts of number of participants are by maximum severity, that is, individuals experiencing more than one episode of a TEAE are counted only once within each preferred term category using the most severe episode.
An ADR was any TEAE where a causal relationship with the administered medicinal product was at least a reasonable possibility.