Death
Drugs: ACALABRUTINIB
- Safetyreportversion
- 1
- Safetyreportid
- 27325217
- Primarysourcecountry
- VN
- Occurcountry
- VN
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 1
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- VN-AstraZeneca-CH-01210268A
- Primarysource
- Reportercountry
- VN
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- ALEXION PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Death
- Reactionoutcome
- 5
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- ACALABRUTINIB
- Drugbatchnumb
- FGBN
- Drugauthorizationnumb
- 210259
- Drugstructuredosagenumb
- 100
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 100 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- ACALABRUTINIB
- Harmonized identifiers (openFDA)
- Application number
- NDA210259
- Brand name
- CALQUENCE
- Generic name
- ACALABRUTINIB
- Manufacturer name
- AstraZeneca Pharmaceuticals LP
- Product NDC
- 0310-0512
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ACALABRUTINIB
- RxCUI
- 1986813, 1986819
- SPL ID
- aa4e8627-21c7-413a-9d0d-1957ded93283
- SPL set ID
- dd4835ef-e1bc-4997-a399-1ffa2556fbfe
- Package NDC
- 0310-0512-60, 0310-0512-28, 0310-0512-95
- Nui
- N0000175605, N0000020001
- Pharm class epc
- Kinase Inhibitor [EPC]
- Pharm class moa
- Tyrosine Kinase Inhibitors [MoA]
- UNII
- I42748ELQW