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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123680116 | 12368011 | 6 | F | 20160701 | 20160513 | 20160708 | EXP | JP-ABBVIE-16P-087-1627649-00 | ABBVIE | SATO M, HARADA M, OISHI H, WADA-HIRAIKE O, HIRATA T, NAGASAKA K, ET AL. VAGINAL STENOSIS AFTER GONADOTROPIN-RELEASING HORMONE AGONIST THERAPY DURING TREATMENT FOR ACUTE LYMPHOBLASTIC LEUKEMIA. JOURNAL OF LOWER GENITAL TRACT DISEASE. 2016;20(2):E11-E13 | 26.00 | YR | F | Y | 44.00000 | KG | 20160708 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123680116 | 12368011 | 1 | PS | LEUPLIN | LEUPROLIDE ACETATE | 1 | Subcutaneous | 1.88 MG, Q4WEEKS | U | 20011 | 1.88 | MG | INJECTION | ||||||
| 123680116 | 12368011 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 60 MG/M2, UNK | U | 0 | 60 | MG/M**2 | |||||||
| 123680116 | 12368011 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 40 MG/M2, UNK | U | 0 | 40 | MG/M**2 | |||||||
| 123680116 | 12368011 | 4 | SS | LEUNASE | ASPARAGINASE | 1 | Intravenous drip | UNK | U | U | 0 | ||||||||
| 123680116 | 12368011 | 5 | SS | LEUNASE | ASPARAGINASE | 1 | Intravenous drip | UNK | U | U | 0 | ||||||||
| 123680116 | 12368011 | 6 | SS | THERARUBICIN | PIRARUBICIN HYDROCHLORIDE | 1 | Intravenous drip | 25 MG/M2, UNK | U | U | 0 | 25 | MG/M**2 | ||||||
| 123680116 | 12368011 | 7 | SS | ONCOVIN | VINCRISTINE SULFATE | 1 | Intravenous (not otherwise specified) | 1.50 MG/M2, UNK | U | U | 0 | 1.5 | MG/M**2 | ||||||
| 123680116 | 12368011 | 8 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 1200 MG/M2, UNK | U | U | 0 | 1200 | MG/M**2 | ||||||
| 123680116 | 12368011 | 9 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 750 MG/M2, UNK | U | U | 0 | 750 | MG/M**2 | ||||||
| 123680116 | 12368011 | 10 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 500 MG/M2, UNK | U | U | 0 | 500 | MG/M**2 | ||||||
| 123680116 | 12368011 | 11 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 600 MG/M2, UNK | U | U | 0 | 600 | MG/M**2 | ||||||
| 123680116 | 12368011 | 12 | SS | DECADRON | DEXAMETHASONE | 1 | Intravenous drip | 10 MG/M2, UNK | U | U | 0 | 10 | MG/M**2 | ||||||
| 123680116 | 12368011 | 13 | SS | CYLOCIDE | CYTARABINE | 1 | Intravenous drip | 75 MG/M2, UNK | U | U | 0 | 75 | MG/M**2 | ||||||
| 123680116 | 12368011 | 14 | SS | LEUKERIN | MERCAPTOPURINE | 1 | Oral | 50 MG/M2, UNK | U | U | 0 | 50 | MG/M**2 | ||||||
| 123680116 | 12368011 | 15 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous drip | 3000 MG/M2, UNK | U | U | 0 | 3000 | MG/M**2 | ||||||
| 123680116 | 12368011 | 16 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous drip | 150 MG/M2, UNK | U | U | 0 | 150 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123680116 | 12368011 | 1 | Prophylaxis |
| 123680116 | 12368011 | 2 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 4 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 6 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 7 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 8 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 12 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 13 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 14 | B precursor type acute leukaemia |
| 123680116 | 12368011 | 15 | B precursor type acute leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123680116 | 12368011 | HO |
| 123680116 | 12368011 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123680116 | 12368011 | Abdominal pain | |
| 123680116 | 12368011 | Amenorrhoea | |
| 123680116 | 12368011 | Haematocolpos | |
| 123680116 | 12368011 | Off label use | |
| 123680116 | 12368011 | Uterine haemorrhage | |
| 123680116 | 12368011 | Vaginal haemorrhage | |
| 123680116 | 12368011 | Vaginal stricture | |
| 123680116 | 12368011 | Vulvovaginal adhesion |
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 |
|---|---|---|---|---|---|---|
| 123680116 | 12368011 | 1 | 20100127 | 20101015 | 0 | |
| 123680116 | 12368011 | 2 | 201001 | 0 | ||
| 123680116 | 12368011 | 10 | 201010 | 0 |