Questions 83-88 refer to data reported on form 2100, Q441-615, please ensure data reported here matches with form 2100.
Questions 83-85: In the transplant physician’s judgment, were any of the disorders / impairments reported on the form 2100 a direct result of the Tepadina® reported administration?
2100 Q441-615: Organ Function form instruction manual:
Indicate if the medical director believes the adverse event to be directly related to the infusion of Tepadina®, check all that apply.
Acute renal failure requiring dialysis
Congestive heart failure
Cryptogenic organizing pneumonia (COP / BOOP)
Deep vein thrombosis (DVT) / Pulmonary embolism (PE)
Diffuse alveolar hemorrhage
GVHD (acute or chronic)
Hypertension (HTN) requiring therapy
Mucositis requiring therapy
Non-infectious interstitial pneumonitis (IPn or ARDS) / idiopathic pneumonia syndrome (IPS)
Questions 86-88: Was this disorder / impairment a serious event?
An event is serious if one of the following applies:
- Death (the event is the cause of death);
- Life-threatening (i.e., immediate risk of death);
- In-patient hospitalization or prolongation of existing hospitalization;
- Persistent or significant disability / incapacity;
- Congenital anomaly / birth defect;
- Important medical events
Indicate if the adverse event was considered a serious event check all that apply.
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