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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119778576 | 11977857 | 6 | F | 20151208 | 20160812 | 20160129 | 20160818 | EXP | PHHY2016AU004719 | SANDOZ | 73.00 | YR | M | Y | 60.00000 | KG | 20160818 | CN | US | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119778576 | 11977857 | 1 | SS | OFATUMUMAB | OFATUMUMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, (EVERY 4 WEEKS) | 0 | 1000 | MG | ||||||||
| 119778576 | 11977857 | 2 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | 22137 | ||||||||||
| 119778576 | 11977857 | 3 | SS | IDELALISIB | IDELALISIB | 1 | Oral | 100 MG, QD | 0 | 100 | MG | TABLET | QD | ||||||
| 119778576 | 11977857 | 4 | SS | R CHOP | CYCLOPHOSPHAMIDEDOXORUBICINPREDNISONERITUXIMABVINCRISTINE | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 7 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 9 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 10 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 11 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 12 | C | ZINC | ZINCINC CHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 13 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 14 | C | CELESTONE | BETAMETHASONE | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 15 | C | IGG | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 16 | C | INTRAGAM P | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | UNK | 0 | SOLUTION FOR INFUSION | |||||||||
| 119778576 | 11977857 | 17 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 18 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | UNK | 0 | ||||||||||
| 119778576 | 11977857 | 19 | C | DURO-K | 2 | Unknown | UNK | 0 | |||||||||||
| 119778576 | 11977857 | 20 | C | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119778576 | 11977857 | 1 | Chronic lymphocytic leukaemia |
| 119778576 | 11977857 | 2 | Product used for unknown indication |
| 119778576 | 11977857 | 3 | Chronic lymphocytic leukaemia |
| 119778576 | 11977857 | 4 | Product used for unknown indication |
| 119778576 | 11977857 | 5 | Product used for unknown indication |
| 119778576 | 11977857 | 6 | Product used for unknown indication |
| 119778576 | 11977857 | 7 | Product used for unknown indication |
| 119778576 | 11977857 | 8 | Product used for unknown indication |
| 119778576 | 11977857 | 9 | Product used for unknown indication |
| 119778576 | 11977857 | 10 | Product used for unknown indication |
| 119778576 | 11977857 | 11 | Product used for unknown indication |
| 119778576 | 11977857 | 12 | Product used for unknown indication |
| 119778576 | 11977857 | 13 | Product used for unknown indication |
| 119778576 | 11977857 | 14 | Skin exfoliation |
| 119778576 | 11977857 | 15 | Product used for unknown indication |
| 119778576 | 11977857 | 16 | Product used for unknown indication |
| 119778576 | 11977857 | 17 | Product used for unknown indication |
| 119778576 | 11977857 | 18 | Product used for unknown indication |
| 119778576 | 11977857 | 19 | Product used for unknown indication |
| 119778576 | 11977857 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119778576 | 11977857 | DE |
| 119778576 | 11977857 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119778576 | 11977857 | Ascites | |
| 119778576 | 11977857 | Atelectasis | |
| 119778576 | 11977857 | Bile duct obstruction | |
| 119778576 | 11977857 | Biliary sepsis | |
| 119778576 | 11977857 | Cardiac failure | |
| 119778576 | 11977857 | Cholangiocarcinoma | |
| 119778576 | 11977857 | Chronic lymphocytic leukaemia | |
| 119778576 | 11977857 | Concomitant disease progression | |
| 119778576 | 11977857 | Escherichia test positive | |
| 119778576 | 11977857 | Genital herpes simplex | |
| 119778576 | 11977857 | Hepatic atrophy | |
| 119778576 | 11977857 | Musculoskeletal disorder | |
| 119778576 | 11977857 | Platelet count decreased | |
| 119778576 | 11977857 | Portal vein occlusion | |
| 119778576 | 11977857 | Septic shock | |
| 119778576 | 11977857 | Splenomegaly |
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 |
|---|---|---|---|---|---|---|
| 119778576 | 11977857 | 1 | 20131015 | 20140325 | 0 | |
| 119778576 | 11977857 | 2 | 200312 | 2004 | 0 | |
| 119778576 | 11977857 | 3 | 20131015 | 20151209 | 0 | |
| 119778576 | 11977857 | 4 | 2008 | 2009 | 0 | |
| 119778576 | 11977857 | 6 | 200312 | 2004 | 0 | |
| 119778576 | 11977857 | 7 | 200312 | 2004 | 0 | |
| 119778576 | 11977857 | 8 | 20151209 | 0 | ||
| 119778576 | 11977857 | 10 | 20131015 | 0 | ||
| 119778576 | 11977857 | 12 | 2003 | 0 | ||
| 119778576 | 11977857 | 13 | 2008 | 0 | ||
| 119778576 | 11977857 | 16 | 20131018 | 0 | ||
| 119778576 | 11977857 | 17 | 20141209 | 0 | ||
| 119778576 | 11977857 | 18 | 20141217 | 0 | ||
| 119778576 | 11977857 | 19 | 20141217 | 0 | ||
| 119778576 | 11977857 | 20 | 20141209 | 0 |