Table 3.
OXi4503-related serious adverse events (SAE).
| A All Study Drug OXi4503-Related SAEs Reported for Patients Treated with OXA in Study OX1222. | ||||||||
|---|---|---|---|---|---|---|---|---|
| Patient No. | Cohort# | SAE Reported Term (CTCAE Grade) | Relatedness with OXi4503 | SAE Outcome | Action Taken | |||
| 106–006 | 2 | Neutropenic Fever (3) | Possibly related | Recovered, without sequelae | None | |||
| 103–010 | 4 | Neutropenic fever (3) | Related | Recovered, without sequelae | None | |||
| 103–012 | 6 | Acute hypoxic respiratory failure (4) | Possibly related | Recovered | None | |||
| 103–012 | 6 | Pneumonia (3) | Possibly related | Not recovered | None | |||
| 106–011 | 6 | Hypotension (3) | Possibly related | Recovered, without sequelae | None | |||
| B Incidence of OXi4503-related SAEs Occurring in patients treated with OXA in study OX1222 by MedDRA PT (any CTCAE Grade). | ||||||||
|
MedDRA SOC
MedDRA PT |
Cohorts | Total | ||||||
| 3.75 mg/m2 | 4.68 mg/m2 | 6.25 mg/m2 | 7.81 mg/m2 | 9.76 mg/m2 | 12.2 mg/m2 |
N = 29
n(%) |
||
| Blood and Lymphatic System Disorders | ||||||||
| Febrile Neutropenia | 0 | 1 | 0 | 1 | 0 | 0 | 2 (6.9) | |
| Respiratory, Thoracic and Mediastinal Disorders | ||||||||
| Acute hypoxic Respiratory Failure | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3.4) | |
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3.4) | |
| Vascular Disorders | ||||||||
| Hypotension | 0 | 0 | 0 | 0 | 0 | 1 | 1 (3.4) | |