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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/17/2011
 
Trade Name:  Alimta
 
Generic or Proper Name (*):  pemetrexed disodium
 
Indications Studied:  Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma
 
Therapeutic Category:  Antineoplastic
 
Ages Studied:  >12 months and d21 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label
 
No Patients:  72
 
No Countries:  2
 
BPCA(B), PREA(P):  B
 
Asian:  2
 
Black:  14
 
White:  48
 
Unknown:  6
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  2
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  US, Canada
 
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