Table 3.
AE summary by dose received at time of event over 12 weeks in the base study
| AE Type | Dosage per Day | Total | |||
|---|---|---|---|---|---|
| Low (0.1 mg/kg) | Medium (0.3 mg/kg) | High (0.7 mg/kg) | Highest (1.4 mg/kg) | ||
| Participants (n) | 34 | 54 | 63 | 33 | 99 |
| Clinical | |||||
| Any clinical AE | 20 (57.1) | 30 (55.6) | 38 (59.4) | 21 (65.6) | 79 (79.8) |
| Any drug-related clinical AEa | 0 (0.0) | 2 (3.7) | 2 (3.2) | 1 (3.0) | 3 (3.0) |
| Any serious clinical AE | 3 (8.8) | 2 (3.7) | 2 (3.2) | 0 (0.0) | 7 (7.1) |
| Any serious drug-related clinical AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Died | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cause of discontinuation of study medicationb | |||||
| Clinical AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Clinical drug-related AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Serious clinical AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Serious drug-related clinical AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Laboratory | |||||
| Any laboratory AE | 1 (2.9) | 1 (1.9) | 0 (0.0) | 0 (0.0) | 2 (2.0) |
| Any drug-related laboratory AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any serious laboratory AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any serious drug-related laboratory AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cause of discontinuation of study medicationb | |||||
| Laboratory AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Drug-related laboratory AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Serious laboratory AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Serious drug-related laboratory AEa | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AEs of clinical interest | 1 (2.9) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 2 (2.0) |
| GFR decreased | 1 (2.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.0) |
| Hypotension | 0 (0.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.0) |
Data are shown as the number of participants in the AE category and percentages are calculated based on the number of participants who received at least one dose of the specified study treatment dose and with follow-up during the base study. Patients could have been counted in more than one dose group according to each dose to which they were exposed during the 12-week randomized phase of the trial; each participant was counted only once in the total column. AE, adverse event.
a
Determined by the investigator to be possibly, probably, or definitely related to the drug. If unknown, the AE was considered to be drug related.
b
Study medication withdrawn.