Note: The following toxicity table is a DRAFT and designed to provide general guidance on parameters for monitoring safety in clinical trials. This toxicity table is not comprehensive and should not be applied directly to all trials.
When lecting a toxicity table, the following are some of the items that must be taken into consideration:
∙ The population being studied
o Does the clinical trial evaluate healthy subjects, subjects with a particular dia or condition?
费用申请单模板
∙ The stage of test article development
o Is the clinical trial a Pha I, II, III or IV?
∙ The type of test article
o Does the clinical trial evaluate a drug, device, vaccine or other biologic agent?
∙ The prior human and preclinical experience with the test article
o Are there any specific findings that require adjustment of the toxicity table?
Single site clinical trials evaluating healthy subjects should conform to the laboratory normal values at the single site. Multi-center clinical trials should reconcile among their laboratory normal values when evaluating a healthy volunteer population.
Plea confer with the DMID protocol team and DMID's Office of Clinical Rearch Affairs when lecting or developing a toxicity table for a DMID-sponsored trial.
ABBREVIATIONS: Abbreviations utilized in the Table:
ULN = Upper Limit of Normal LLN = Lower Limit of Normal
R蒜茸x = Therapy Req = Required
Mod = Moderate IV = Intravenous
斗折蛇行的意思ADL = Activities of Daily Living Dec = Decread
ESTIMATING SEVERITY GRADE
For abnormalities NOT found elwhere in the Toxicity Tables u the scale below to estimate grade of verity:
GRADE 1 Mild Transient or mild discomfort
(< 48 hours); no medical intervention/therapy required
GRADE 2 Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required
GRADE 3 Severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible
GRADE 4 Life-threatening Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable
SERIOUS OR LIFE-THREATENING AEs
ANY clinical event deemed by the clinician to be rious or life-threatening should be considered a grade 4 event. Clinical events considered to be rious or life-threatening include, but are not limited to: izures, coma, tetany, diabetic ketoacidosis, disminated intravascular coagulation, diffu petechiae, paralysis, acute psychosis, vere depression.
COMMENTS REGARDING THE USE OF THESE TABLES
• Standardized and commonly ud toxicity tables (Division of AIDS, NCI’s Common Toxicity Criteria (CTC), and World Health Organization (WHO)) have been adapted for u by the Division of Microbiology and Infectious Dias (DMID) and modified to better meet the needs of participants in DMID trials.
• For parameters not included in the following Toxicity Tables, sites should refer to the “Guide For Estimating Severity Grade” located above.
• Criteria are generally grouped by body system.
• Some protocols may have additional protocol specific grading criteria, which will supercede the u of the tables for specified criteria.
HEMATOLOGY |
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
Hemoglobin | 9.5 - 10.5 gm/dL | 8.0 - 9.4gm/dL | 6.5 - 7.9 gm/dL | < 6.5 gm/dL |
Absolute Neutrophil Count | 1000-1500/mm3 | 750-999/mm3 | 500-749/mm3 | <500/mm3 |
Platelets | 75,000-99,999/mm3 | 敬佩英文 50,000-74,999/mm3 | 20,000-49,999/mm3 | <20,000/mm3 |
WBCs | 11,000-13,000/ mm3 | 菊花能吃吗13,000- 15,000 /mm3 | 15,000- 30,000/mm3 | >30,000 or <1,000 /mm3 |
% Polymorphonuclear Leucocytes + Band Cells | > 80% | 90 – 95% | >95% | ---------- |
Abnormal Fibrinogen | Low: 100-200 mg/dL High: 400-600 mg/dL | Low: <100 mg/dL High: >600 mg/dL | Low: < 50 mg/dL ---------- | Fibrinogen associated with gross bleeding or with disminated coagulation |
Fibrin Split Product | 20-40 mcg/ml | 41-50 mcg/ml | 51-60 mcg/ml | > 60 mcg/ml |
Prothrombin Time (PT) | 1.01 - 1.25 x ULN | 1.26-1.5 x ULN | 1.51 -3.0 x ULN | >3 x ULN |
Activated Partial Thromboplastin (APPT) | 1.01 -1.66 x ULN | 1.67 - 2.33 x ULN | 2.34 - 3 x ULN | > 3 x ULN |
Methemoglobin | 5.0 - 9.9 % | 10.0 - 14.9 % | 豆腐白菜的做法15.0 - 19.9% | > 20.0 % |
| | | | |
CHEMISTRIES |
| Grade 1 | Grade 2 | Grade 3 新年新诗会 | Grade 4 |
Hyponatremia | 130-135 mEq/L | 123-129 mEq/L | 116-122 mEq/L | < 116 mEq/L or abnormal sodium with mental status changes or izures |
Hypernatremia | 146-150 mEq/L | 151-157 mEq/L | 158-165 mEq/L | > 165 mEq/L or abnormal sodium with mental status changes or izures |
Hypokalemia | 3.0 - 3.4 mEq/L | 2.5 - 2.9 mEq/L | 2.0 - 2.4 mEq/L or intensive replacement therapy or hospitalization required | < 2.0 mEq/L or abnormal potassium with paresis, ileus or life-threatening arrhythmia |
Hyperkalemia | 5.6 - 6.0 mEq/L | 6.1 - 6.5 mEq/L | 6.6 - 7.0 mEq/l | > 7.0 mEq/L or abnormal potassium with life-threatening arrhythmia |
Hypoglycemia | 55-64 mg/dL | 40-54 mg/dL | 30-39 mg/dL | <30 mg/dL or abnormal gluco with mental status changes or coma |
Hyperglycemia 一切景语皆情语(nonfasting and no prior diabetes) | 116 - 160 mg/dL | 161- 250 mg/dL | 251 - 500 mg/dL | > 500 mg/dL or abnormal gluco with ketoacidosis or izures |
Hypocalcemia (corrected for albumin) | 8.4 - 7.8 mg/dL | 7.7 - 7.0 mg/dL | 6.9 - 6.1 mg/dL | < 6.1 mg/dL or abnormal calcium with life threatening arrhythmia or tetany |
| | | | |
