Question 1: Were there any Grade ≥ 3 potentially immune-mediated complications of interest?

Indicate whether the recipient experienced a Grade ≥ 3 potentially immune-mediated complication of interest during the timeframe captured by the specific visit ID of form 2542 . Only report the following Grade ≥3 immune-mediated complications of interest:

  • Polymyositis
  • Autoimmune Thyroiditis
  • Autoimmune Hepatitis
  • Myositis
  • Pneumonitis/Interstitial Lung Disease
  • Myocarditis
  • Polyneuropathy (Guillain-Barre Syndrome and its variants)
  • Dermatitis/rash (not considered GVHD)
  • Encephalitis.

If no Grade ≥ 3 potentially immune-mediated complications of interest occurred (timeframe), report “no” for question 1 and go to question 4.Please use the referenced table here for grading criteria.

Complete questions 2-3 for each specific complication of interest.

Questions 2-3: Specify Grade ≥ 3 potentially immune- mediated complication of interest.

Specify each Grade ≥3 potentially immune-mediated complications of interest that occurred (in the reporting timeframe) in question 2 and report the date (YYYY-MM-DD) when the complication initially occurred in question 3.

Copy and complete questions 2-3 to report more than one Grade ≥3 potentially immune-mediated complication of interest.

Section Updates:

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

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