ADVL0212: Reporting Period Worksheet (Leukemia) FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder:

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 3/12/15 3/12/15 - Martin Dugas
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March 12, 2015

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Creative Commons BY-NC 3.0 Legacy
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Brain and Central Nervous System Tumors NCT00053963 Treatment - ADVL0212: Reporting Period Worksheet (Leukemia) - 2172521v3.0

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  1. StudyEvent: ADVL0212: Reporting Period Worksheet (Leukemia)
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Patient characteristics
Was patient's bone marrow status evaluated during this reporting interval?
does patient have bone marrow involvement?
Was patients shortening fraction determined by echocardiogram?
Is patient off protocol therapy at the end of this reporting period?
reason treatment ended
Did resting heart rate increase by 35%?
check all that apply
check all that apply
Was there a T wave inversion in leads II, III, AVF (inferior leads) or V4, V5, and V6 (lateral leads)?
Was ST segment at the J-point greater than or equal to 2 mm below baseline in leads II, II AVF (inferior leads), V4, V5, V6 (lateral leads)?
Was there a change to LVEF?
Were any of the infusions of Depsipeptide interrupted for any reason?
Was there a deviation from protocol therapy?
Did the patient receive radiation therapy during this reporting period?
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)?
Concomitant Medication
Did patient receive concomitant medications while on protocol therapy?
New Cancer
Has a new primary cancer of MDS been diagnosed that has not been previously reported?
Vital Status
Was the patient unable to be contacted for current scheduled follow-up?
Was patient enrolled on another COG therapeutic study at the end of this reporting period?
Was patient's consent withdrawn?
Did patient relapse or experience disease progression during this reporting period?
Adverse event
Adverse Drug Experience?
Dose Limiting Toxicity?
check box if not resolved [toxicity]

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