Table 2.
Summary of AEs
| Category of AE | 0.5 mg TAK‐954 | 10 mg Metoclopramide | Day Reported (Relative to Baseline) |
|---|---|---|---|
| Total number of patients, n | 7 | 6 | – |
| Total number of AEs, n | 8 | 5 | – |
| Participants identified to have at least 1 AEa, n (%) | 5 (71) | 4 (67) | – |
| Participant AE reported as moderate or severe, n (%) | 3 (43) | 3 (50) | – |
| Cerebral hemorrhage | 1 (14) | 0 (0) | 3 |
| Intracranial hemorrhage | 0 (0) | 1 (17) | 3 |
| Subarachnoid hemorrhage | 0 (0) | 1 (17) | 7 |
| Disease progression | 0 (0) | 1 (17) | 6 |
| Respiratory failure | 1 (14) | 0 (0) | 11 |
| Decubitus ulcer | 1 (14) | 0 (0) | 7 |
| Hypertension | 0 (0) | 1 (17) | 3 |
| Treatment‐related moderate or severe AEs, n (%) | 0 (0) | 0 (0) | – |
| Serious AEs, n (%) | 2 (29) | 3 (50) | |
| Cerebral hemorrhage | 1 (14) | 0 (0) | 3 |
| Intracranial hemorrhage | 0 (0) | 1 (17) | 3 |
| Subarachnoid hemorrhage | 0 (0) | 1 (16) | 7 |
| Disease progression | 0 (0) | 1 (16) | 6 |
| Respiratory failure | 1 (14) | 0 (0) | 11 |
| Treatment‐related serious AEsb, n (%) | 0 (0) | 0 (0) | – |
| AEs leading to discontinuation of treatment, n (%) | 0 (0) | 0 (0) | – |
| Any AEs leading to treatment interruption, n (%) | 0 (0) | 0 (0) | – |
| Deathsb, n (%) | 2 (29) | 3 (50) | – |
AE, adverse event.
a
Only 1 AE (mild diarrhea in the metoclopramide group) was considered to be potentially treatment related.
b
No serious AEs (including deaths) were considered to be treatment related in either group.