Table 3. Drug-related adverse events as defined by the site investigator, n (%).
| Placebo (n=40) | 0.8 g LT-02 (n=40) | 1.6 g LT-02 (n=41) | 3.2 g LT-02 (n=35) | |
|---|---|---|---|---|
| ADRs | 6 (15.0%)a | 5 (12.5%)a | 3 (7.3%)a | 4 (11.4%)a |
| Tachyarrhythmia | 1 (2.5%) | 0 | 0 | 0 |
| Abd. distension/flatulence | 5 (12.5%) | 2 (5.0%) | 2 (4.9%) | 1 (2.9%) |
| Constipation | 0 | 0 | 0 | 1 (2.9%) |
| Nausea | 0 | 1 (2.5%) | 0 | 0 |
| Vomiting | 0 | 1 (2.5%) | 0 | 1 (2.9%) |
| Asthenia | 0 | 0 | 0 | 1 (2.9%) |
| Chills | 0 | 0 | 0 | 1 (2.9%) |
| Edema | 0 | 0 | 1 (2.4%) | 0 |
| Pain | 0 | 0 | 0 | 1 (2.9%) |
| Arthralgia | 0 | 0 | 1 (2.4%) | 0 |
| Headache | 0 | 1 (2.5%) | 1 (2.4%) | 1 (2.9%) |
| Proteinuria | 0 | 1 (2.5%) | 0 | 0 |
| Pruritus | 0 | 0 | 1 (2.4%) | 0 |
Abd., abdominal; ADR, adverse drug reaction.
Coded according to MedDRA, Version 13.0.
a
No. of patients with at least one ADR; some patients had multiple ADRs.
There was no evidence for any treatment-related difference of adverse events (AEs). As may be expected from the patient population and the disease under treatment in this study, gastrointestinal AEs as well as infections were the most frequent AEs. Neither these nor other AEs showed any treatment-related differences.