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Instructions for Adverse Events Clinical Questions Form

You will note that many fields are the same on the Individual Graphics Form, the ECG Vitals Graphics Form, and the Adverse Events Form. The Instructions for Completing Individual Graphics Form are particularly helpful for attaching images and code.

  • We have added a Figure No. for the Adverse Events Graphs to help with indexing.

Completing Question Classification and Clinical Questions Answered Fields

Choose as many question classifications as are reflected in your graph:

  • I-Demographics
  • II-Incidence of AE:1_Types of AE (treatment vs comparators or different dosage)
  • II-Incidence of AE:2_Incidence rate or ratio
  • III-AE Occurrence Over Time:1_Time to onset (treatment vs comparator)
  • III-AE Occurrence Over Time:2_Trends of AE occurrence over time
  • IV-Dosage and Exposure:1_AE occurrence across different dosages
  • IV-Dosage and Exposure:2_AE occurrence and treatment effects (i.e. efficacy)
  • V-Potential Risk Factors or Temporal Relationship of AE:1_Baseline factors
  • V-Potential Risk Factors or Temporal Relationship of AE:2_Concomitant medications
  • V-Potential Risk Factors or Temporal Relationship of AE:3_AE event of interest in relationship with other prior or concurred AEs
  • V!-Withdraw and Interruption in Relation to the Occurrence of AEs, VII-Patient Profile

Choose as many clinical questions answered in your graph:

  • I-Which adverse events are elevated in patient subgroups (race or gender or age?
  • II-1-Which AEs are elevated in treament vs control? Is the occurrence of AEs elevated in particular patient subgroups?
  • II-2-What is the treatment of treatment effects over time - e.g. risk difference or risk ratios or odds ratio?
  • II-3-Are there any event groups of special interest (e.g. cardiovascular events or hepatic event)?
  • II-4-What is the safety profile of the drug?
  • III-1 Are there any special patterns of an AE onset? Are there any cyclical and/or seasonal patterns in AE occurrence over drug use?
  • III-2-Is there a difference in the time to event across treatment groups?
  • IV-1-What is the relationship between AE occurrence and drug exposure?
  • V-1-Is there a relationship with other AEs?
  • V-2-Is there a temporal relationship between drug exposure and AE occurrence?
  • V-3-Are there any risk factors in relation to AE occurrence?
  • V-4-How do drug-drug interactions relate to AE occurrence?
  • V-5-Is there a relationship between AE occurrence and concomitant medication use?
  • VI-1-Are there any AEs associated with drop-outs?
  • VII-1-What is the patient profile - that is - study drug or dose or concomitant medications or laboratory values or adverse events?
  • VII-2-Are laboratory elevations related to adverse events? Are laboratory elevations and adverse events related to treatments?| Mark all questions answered.

Reference Images and Enlargement of Reference Images

We need two images to use the Lightbox Plugin?, which gives the reader the opportunity to enlarge a smaller image.

  • Recommended size for Reference Image, Thumbnail, or smaller images is 200 pixels.
  • Recommended size for larger images is 500-600 pixels. (The wiki has no size limitations but large images do not fit in one screen.)
Topic revision: r3 - 14 Nov 2012 - 13:09:55 - MaryBanach

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