Description:

Adverse Event Form (Form 24-AE) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7

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Versions (2) ▾
  1. 8/26/12
  2. 1/9/15
Uploaded on:

January 9, 2015

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License:
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Adverse Event Form (Form 24-AE) - 2072124v3.0

Instructions: Indicate whether or not the patient experienced any of the adverse events listed below by marking an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done. This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 & 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No AE Forms are required after first relapse/recurrence.

Sexual/reproductive Function
Relation to study treatment(s)
Relation to study treatment(s)
Relation to study treatment(s)
Relation to study treatment(s)
Was the patient treated for vaginal dryness or dyspareunia?
Vasomotor Menopausal
Relation to study treatment(s)
Was patient treated for hot flashes/night sweats?
Musculoskeletal
Bone Mineral Densitometry Performed
If yes, was bone mineral density T-score at least 1.5 standard deviations below the young adult normal mean in at least one site?
Relation to study treatment(s)
Relation to study treatment(s)
Bone Fractures
Main cause of bone fracture (select all that apply)
Site of bone fracture (select all that apply)
Psychological
Relation to study treatment(s)
Cardiovascular/cerebrovascular
Hypertension (treated?) (Treated?)
Relation to study treatment(s)
Relation to study treatment(s)
Relation to study treatment(s)
Relation to study treatment(s)
Constitutional Symptoms
Relation to study treatment(s)
Relation to study treatment(s)
Relation to study treatment(s)
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Relation to study treatment(s)
Relation to study treatment(s)
If possibly, probably or definitely related to study treatment, in the Investigator?s opinion, the event was most likely due to: (select one)
Other Adverse Events
Did the patient have other Grade 3 or higher adverse event(s)? (Use terminology and grading from CTC)
Relation to study treatment(s)
Ccrr Module For Adverse Event Form (form 24-ae)

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