Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113133746 | 11313374 | 6 | F | 20150710 | 20160819 | 20150727 | 20160831 | EXP | DE-BAXALTA-2015BLT000620 | BAXALTA | 18.00 | YR | M | Y | 77.40000 | KG | 20160831 | MD | DE | DE |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113133746 | 11313374 | 1 | PS | FEIBA NF | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 5000 IU, EVERY OTHER DAY | VNF2P020A | 140 | 5000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | ||||||
| 113133746 | 11313374 | 2 | SS | FEIBA NF | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | 140 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||||
| 113133746 | 11313374 | 3 | C | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | UNK UNK, AS NEEDED | U | 0 | 1X | ||||||||
| 113133746 | 11313374 | 4 | C | ARCOXIA | ETORICOXIB | 1 | Oral | 90 MG, AS NEEDED | U | 0 | 90 | MG | 1X | ||||||
| 113133746 | 11313374 | 5 | C | Ibuprofen al | IBUPROFEN | 1 | Oral | 600 MG, AS NEEDED | U | 0 | 600 | MG | 1X | ||||||
| 113133746 | 11313374 | 6 | C | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | Intravenous (not otherwise specified) | UNK UNK, AS NEEDED | U | 0 | 1X | ||||||||
| 113133746 | 11313374 | 7 | C | Cefuroxim | CEFUROXIME | 1 | Oral | UNK UNK, AS NEEDED | U | 0 | 1X | ||||||||
| 113133746 | 11313374 | 8 | C | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Oral | 250 MG, 2X A DAY | 4000 | MG | 0 | 250 | MG | BID | |||||
| 113133746 | 11313374 | 9 | C | Ferrosanol | FERROUS GLUCONATE | 1 | Oral | 100 MG, 2X A DAY | 0 | 100 | MG | BID | |||||||
| 113133746 | 11313374 | 10 | C | Metronidazol | METRONIDAZOLE | 1 | Oral | 400 MG, 2X A DAY | 6400 | MG | 0 | 400 | MG | BID | |||||
| 113133746 | 11313374 | 11 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, 2X A DAY | 640 | MG | 0 | 40 | MG | BID | |||||
| 113133746 | 11313374 | 12 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, 2X A DAY | 0 | 40 | MG | BID | |||||||
| 113133746 | 11313374 | 13 | C | DICLOFENAC | DICLOFENAC | 1 | Oral | UNK | 0 | ||||||||||
| 113133746 | 11313374 | 14 | C | NOVALGIN | METAMIZOLE SODIUM | 1 | Oral | DROPS, AS NEEDED | 0 | 1X | |||||||||
| 113133746 | 11313374 | 15 | C | ZACPAC | AMOXICILLINCLARITHROMYCINPANTOPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113133746 | 11313374 | 1 | Prophylaxis |
| 113133746 | 11313374 | 2 | Haemophilia A with anti factor VIII |
| 113133746 | 11313374 | 3 | Haemorrhage |
| 113133746 | 11313374 | 4 | Arthritis |
| 113133746 | 11313374 | 5 | Arthritis |
| 113133746 | 11313374 | 6 | Device related infection |
| 113133746 | 11313374 | 7 | Device related infection |
| 113133746 | 11313374 | 8 | Gastrointestinal haemorrhage |
| 113133746 | 11313374 | 9 | Iron deficiency |
| 113133746 | 11313374 | 10 | Helicobacter infection |
| 113133746 | 11313374 | 11 | Gastrointestinal haemorrhage |
| 113133746 | 11313374 | 12 | Helicobacter test positive |
| 113133746 | 11313374 | 13 | Arthropathy |
| 113133746 | 11313374 | 14 | Pain |
| 113133746 | 11313374 | 15 | Helicobacter test positive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113133746 | 11313374 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113133746 | 11313374 | Device related infection | |
| 113133746 | 11313374 | Thrombosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 113133746 | 11313374 | 1 | 20150710 | 20150710 | 0 | |
| 113133746 | 11313374 | 3 | 20141223 | 0 | ||
| 113133746 | 11313374 | 4 | 20141223 | 0 | ||
| 113133746 | 11313374 | 5 | 20141223 | 0 | ||
| 113133746 | 11313374 | 6 | 20141224 | 0 | ||
| 113133746 | 11313374 | 7 | 20141224 | 0 | ||
| 113133746 | 11313374 | 8 | 20150609 | 20150616 | 0 | |
| 113133746 | 11313374 | 9 | 20150209 | 0 | ||
| 113133746 | 11313374 | 10 | 20150609 | 20150616 | 0 | |
| 113133746 | 11313374 | 11 | 20150609 | 20150616 | 0 | |
| 113133746 | 11313374 | 12 | 20150209 | 0 | ||
| 113133746 | 11313374 | 13 | 201505 | 201506 | 0 | |
| 113133746 | 11313374 | 14 | 20150604 | 20150622 | 0 |