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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118070978 | 11807097 | 8 | F | 2015 | 20160916 | 20151207 | 20160930 | EXP | CA-TAKEDA-2015TUS014747 | TAKEDA | 46.00 | YR | F | Y | 0.00000 | 20160930 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118070978 | 11807097 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 315477 | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 118070978 | 11807097 | 2 | SS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, Q4WEEKS | 341419 | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 118070978 | 11807097 | 3 | SS | Pantoloc | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | ENTERIC COATED TABLET | QD | ||||||
| 118070978 | 11807097 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 4 MG, QD | U | U | 0 | 4 | MG | QD | |||||
| 118070978 | 11807097 | 5 | SS | VENOFER | IRON SUCROSE | 1 | Intravenous (not otherwise specified) | UNK, Q2WEEKS | U | 0 | SOLUTION FOR INJECTION | QOW | |||||||
| 118070978 | 11807097 | 6 | SS | CEFTRIAXONE. | CEFTRIAXONE | 1 | Intravenous (not otherwise specified) | 2 G, QD | Y | 0 | 2 | G | QD | ||||||
| 118070978 | 11807097 | 7 | SS | ANCEF | CEFAZOLIN SODIUM | 1 | Intravenous (not otherwise specified) | 2 G, QD | U | 0 | 2 | G | QD | ||||||
| 118070978 | 11807097 | 8 | SS | APO-CEPHALEX | CEPHALEXIN | 1 | Unknown | UNK | 0 | ||||||||||
| 118070978 | 11807097 | 9 | SS | KETOLEX | KETOROLAC TROMETHAMINE | 1 | Oral | 500 MG, QID | Y | 0 | 500 | MG | QID | ||||||
| 118070978 | 11807097 | 10 | SS | VANCOMYCIN HYDROCHLORIDE. | VANCOMYCIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 118070978 | 11807097 | 11 | SS | FRAGMIN | DALTEPARIN SODIUM | 1 | Subcutaneous | 15000 UNITS, QD | 0 | 15000 | IU | QD | |||||||
| 118070978 | 11807097 | 12 | SS | FRAGMIN | DALTEPARIN SODIUM | 1 | 0 | ||||||||||||
| 118070978 | 11807097 | 13 | C | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 1 | 180 MG, QD | U | 0 | 180 | MG | QD | |||||||
| 118070978 | 11807097 | 14 | C | SALOFALK /00000301/ | MESALAMINE | 1 | UNK, QD | U | 0 | TABLET | QD | ||||||||
| 118070978 | 11807097 | 15 | C | SALOFALK /00000301/ | MESALAMINE | 1 | 8 DF, QD | U | 0 | 8 | DF | TABLET | QD | ||||||
| 118070978 | 11807097 | 16 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Oral | 400 MG, UNK | U | 0 | 400 | MG | |||||||
| 118070978 | 11807097 | 17 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Oral | 200 MG, 3/WEEK | U | 0 | 200 | MG | TIW | ||||||
| 118070978 | 11807097 | 18 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Oral | 200 MG, BID | U | 0 | 200 | MG | BID | ||||||
| 118070978 | 11807097 | 19 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 10 MG, 1/WEEK | Y | U | 0 | 10 | MG | /wk | |||||
| 118070978 | 11807097 | 20 | C | IMOVAN | 2 | 7.5 MG, Q1HR | U | 0 | 7.5 | MG | /hr | ||||||||
| 118070978 | 11807097 | 21 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 1 MG, UNK | U | 0 | 1 | MG | ||||||||
| 118070978 | 11807097 | 22 | C | STEMETIL /00013301/ | PROCHLORPERAZINE | 1 | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 118070978 | 11807097 | 23 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 118070978 | 11807097 | 24 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 118070978 | 11807097 | 25 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118070978 | 11807097 | 1 | Colitis ulcerative |
| 118070978 | 11807097 | 3 | Product used for unknown indication |
| 118070978 | 11807097 | 4 | Product used for unknown indication |
| 118070978 | 11807097 | 5 | Abscess |
| 118070978 | 11807097 | 6 | Abscess |
| 118070978 | 11807097 | 7 | Abscess |
| 118070978 | 11807097 | 8 | Abscess |
| 118070978 | 11807097 | 9 | Abscess |
| 118070978 | 11807097 | 10 | Abscess |
| 118070978 | 11807097 | 11 | Deep vein thrombosis |
| 118070978 | 11807097 | 12 | Phlebitis |
| 118070978 | 11807097 | 19 | Systemic lupus erythematosus |
| 118070978 | 11807097 | 22 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118070978 | 11807097 | OT |
| 118070978 | 11807097 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118070978 | 11807097 | Abscess | |
| 118070978 | 11807097 | Abscess limb | |
| 118070978 | 11807097 | Breast abscess | |
| 118070978 | 11807097 | Burning sensation | |
| 118070978 | 11807097 | Colitis ulcerative | |
| 118070978 | 11807097 | Diarrhoea haemorrhagic | |
| 118070978 | 11807097 | Erythema | |
| 118070978 | 11807097 | Erythema nodosum | |
| 118070978 | 11807097 | Haematoma | |
| 118070978 | 11807097 | Infusion site erythema | |
| 118070978 | 11807097 | Infusion site oedema | |
| 118070978 | 11807097 | Infusion site pain | |
| 118070978 | 11807097 | Infusion site warmth | |
| 118070978 | 11807097 | Secretion discharge | |
| 118070978 | 11807097 | Tooth abscess | |
| 118070978 | 11807097 | Wound |
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 |
|---|---|---|---|---|---|---|
| 118070978 | 11807097 | 1 | 20150821 | 0 | ||
| 118070978 | 11807097 | 3 | 20150101 | 0 | ||
| 118070978 | 11807097 | 5 | 201409 | 0 | ||
| 118070978 | 11807097 | 6 | 20150913 | 20150916 | 0 | |
| 118070978 | 11807097 | 7 | 20150916 | 0 | ||
| 118070978 | 11807097 | 9 | 20150918 | 20151002 | 0 | |
| 118070978 | 11807097 | 10 | 20150914 | 20150916 | 0 | |
| 118070978 | 11807097 | 14 | 201501 | 201503 | 0 | |
| 118070978 | 11807097 | 19 | 20150908 | 0 |