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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103554697 | 10355469 | 7 | F | 20140719 | 20160624 | 20140731 | 20160630 | EXP | AU-JNJFOC-20140716493 | PHARMACYCLICS | 69.59 | YR | E | M | Y | 117.00000 | KG | 20160630 | CN | AU | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103554697 | 10355469 | 1 | PS | IBRUTINIB | IBRUTINIB | 1 | Oral | N | 4367302;83497 | 205552 | 560 | MG | CAPSULE | QD | |||||
| 103554697 | 10355469 | 2 | SS | IBRUTINIB | IBRUTINIB | 1 | Oral | N | 4367302;83497 | 102688 | 560 | MG | CAPSULE | QD | |||||
| 103554697 | 10355469 | 3 | SS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | N | 4367321 | 0 | 216 | MG | POWDER | ||||||
| 103554697 | 10355469 | 4 | SS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | N | 4367321 | 0 | 216 | MG | POWDER | ||||||
| 103554697 | 10355469 | 5 | SS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | N | 4367321 | 0 | 216 | MG | POWDER | ||||||
| 103554697 | 10355469 | 6 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N | 14G07BM00267 | 0 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 103554697 | 10355469 | 7 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N | 14G07BM00267 | 0 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 103554697 | 10355469 | 8 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | Oral | QPM EVERY EVENING | 0 | 1500 | MG | UNSPECIFIED | QD | ||||||
| 103554697 | 10355469 | 9 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 0 | 90 | MG | UNSPECIFIED | ||||||||
| 103554697 | 10355469 | 10 | C | INSULIN ASPART | INSULIN ASPART | 1 | Subcutaneous | 22 UNITS,QPM (EVERY EVENING) | 0 | UNSPECIFIED | |||||||||
| 103554697 | 10355469 | 11 | C | INSULIN ASPART | INSULIN ASPART | 1 | Subcutaneous | 14 UNITS, QAM (IN THE MORNING) | 0 | UNSPECIFIED | |||||||||
| 103554697 | 10355469 | 12 | C | TELMISARTAN. | TELMISARTAN | 1 | Oral | QAM (IN THE MORNING) | 0 | 40 | MG | UNSPECIFIED | QD | ||||||
| 103554697 | 10355469 | 13 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | QAM (IN THE MORNING) | 0 | 2 | MG | UNSPECIFIED | QD | ||||||
| 103554697 | 10355469 | 14 | C | EZETROL | EZETIMIBE | 1 | Oral | QAM (IN THE MORNING) | 0 | 10 | MG | UNSPECIFIED | QD | ||||||
| 103554697 | 10355469 | 15 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 103554697 | 10355469 | 16 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1330 | MG | UNSPECIFIED | ||||||||
| 103554697 | 10355469 | 17 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | STAT IMMEDIATELY | 0 | 80 | MG | UNSPECIFIED | |||||||
| 103554697 | 10355469 | 18 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Oral | HS (AT BED TIME) | 0 | 20 | MG | UNSPECIFIED | |||||||
| 103554697 | 10355469 | 19 | C | OXAZEPAM. | OXAZEPAM | 1 | Oral | HS (AT BED TIME) | 0 | 30 | MG | UNSPECIFIED | |||||||
| 103554697 | 10355469 | 20 | C | OXAZEPAM. | OXAZEPAM | 1 | Oral | HS (AT BED TIME) | 0 | 15 | MG | UNSPECIFIED | |||||||
| 103554697 | 10355469 | 21 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 103554697 | 10355469 | 22 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103554697 | 10355469 | 1 | Mantle cell lymphoma |
| 103554697 | 10355469 | 2 | Mantle cell lymphoma |
| 103554697 | 10355469 | 3 | Mantle cell lymphoma |
| 103554697 | 10355469 | 4 | Mantle cell lymphoma |
| 103554697 | 10355469 | 5 | Mantle cell lymphoma |
| 103554697 | 10355469 | 6 | Mantle cell lymphoma |
| 103554697 | 10355469 | 7 | Mantle cell lymphoma |
| 103554697 | 10355469 | 18 | Insomnia |
| 103554697 | 10355469 | 19 | Insomnia |
| 103554697 | 10355469 | 20 | Insomnia |
| 103554697 | 10355469 | 21 | Nausea |
| 103554697 | 10355469 | 22 | Diarrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103554697 | 10355469 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103554697 | 10355469 | Oedema peripheral | |
| 103554697 | 10355469 | Pleural effusion | |
| 103554697 | 10355469 | Rash maculo-papular |
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 |
|---|---|---|---|---|---|---|
| 103554697 | 10355469 | 1 | 20140708 | 20140722 | 0 | |
| 103554697 | 10355469 | 2 | 20140805 | 20140823 | 0 | |
| 103554697 | 10355469 | 3 | 20140708 | 0 | ||
| 103554697 | 10355469 | 4 | 20140708 | 0 | ||
| 103554697 | 10355469 | 5 | 20140805 | 0 | ||
| 103554697 | 10355469 | 6 | 20140708 | 0 | ||
| 103554697 | 10355469 | 7 | 20140805 | 0 | ||
| 103554697 | 10355469 | 18 | 20140701 | 0 | ||
| 103554697 | 10355469 | 19 | 20140701 | 0 | ||
| 103554697 | 10355469 | 20 | 20140701 | 0 | ||
| 103554697 | 10355469 | 21 | 20140711 | 0 | ||
| 103554697 | 10355469 | 22 | 20140718 | 0 |