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
Bronchial obliterans
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
New malignancy
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.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Dec 22, 2020

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