Table 3.
Summary of serious adverse events experienced by patients receiving P276-00.
System Organ Class a | Preferred Term a | Grade a | Relationship to Study Drug | Action Taken with Study Drug | Other Action Taken | Outcome |
---|---|---|---|---|---|---|
Investigations | Blood creatinine increased | 2 | None/Unrelated | Discontinued | Hospitalization | Ongoing |
Respiratory, thoracic and mediastinal disorders | Dyspnea | 3 | None/Unrelated | None | None | Ongoing |
Cardiac disorders | Atrial fibrillation | 3 | None/Unrelated | None | Hospitalization | Complete Recovery |
Infections and infestations | Herpes zoster | 3 | Possible | Discontinued | Hospitalization | Complete Recovery |
Blood and lymphatic system disorders | Thrombocytopenia | 4 | Possible | None | Transfusion | Ongoing |
General disorders and administration site conditions | Disease progression | 5 | Unlikely | None | Medication Given | Death |
General disorders and administration site conditions | Disease progression | 5 | None/Unrelated | Discontinued | None | Death |
Terminology and definitions are taken from the National Cancer Institute's Common Terminology Criteria of Adverse Events.