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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123148834 | 12314883 | 4 | F | 20160201 | 20160725 | 20160428 | 20160802 | EXP | US-JNJFOC-20160417410 | JANSSEN | 59.66 | YR | A | F | Y | 84.37000 | KG | 20160802 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123148834 | 12314883 | 1 | SS | DARZALEX | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 123148834 | 12314883 | 2 | PS | DARZALEX | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123148834 | 12314883 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | U | U | 0 | LYOPHILIZED POWDER | ||||||||
| 123148834 | 12314883 | 4 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 60 | MG | CAPSULE | ||||||||
| 123148834 | 12314883 | 5 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 60 | MG | CAPSULE | ||||||||
| 123148834 | 12314883 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 60 | MG | CAPSULE | ||||||||
| 123148834 | 12314883 | 7 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | TABLET | Q6H | |||||||
| 123148834 | 12314883 | 8 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG | TABLET | BID | |||||||
| 123148834 | 12314883 | 9 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 30 | MG | TABLET | Q12H | |||||||
| 123148834 | 12314883 | 10 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | Respiratory (inhalation) | 200 MCG/5 MCH INHALER | 0 | 200 | UG | AEROSOLS | |||||||
| 123148834 | 12314883 | 11 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | 0 | 10 | MG | ||||||||||
| 123148834 | 12314883 | 12 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | 0 | 10 | MG | ||||||||||
| 123148834 | 12314883 | 13 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | 0 | 25 | MG | BID | |||||||||
| 123148834 | 12314883 | 14 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Oral | 0 | 100 | MG | CAPSULE | TID | |||||||
| 123148834 | 12314883 | 15 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Oral | 0 | 100 | MG | CAPSULE | TID | |||||||
| 123148834 | 12314883 | 16 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 0 | 17 | G | |||||||||
| 123148834 | 12314883 | 17 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 0 | 17 | G | |||||||||
| 123148834 | 12314883 | 18 | C | KYO-DOPHILUS | 2 | 0 | |||||||||||||
| 123148834 | 12314883 | 19 | C | MULTIVITAMINS | VITAMINS | 1 | 0 | ||||||||||||
| 123148834 | 12314883 | 20 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | +ACETYL L-CARNITINE HCL 500 MG | 0 | 300 | MG | BID | ||||||||
| 123148834 | 12314883 | 21 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 0 | 2000 | IU | QD | |||||||||
| 123148834 | 12314883 | 22 | C | TURMERIC | TURMERIC | 1 | 0 | 1330 | MG | QD | |||||||||
| 123148834 | 12314883 | 23 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | |||||||||
| 123148834 | 12314883 | 24 | C | ATIVAN | LORAZEPAM | 1 | Intravenous (not otherwise specified) | 0 | .5 | MG | |||||||||
| 123148834 | 12314883 | 25 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 123148834 | 12314883 | 26 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | 1000 | MG | UNSPECIFIED | |||||||||
| 123148834 | 12314883 | 27 | C | PEPCID | FAMOTIDINE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 123148834 | 12314883 | 28 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 2 PUFFS EVERY 4-6 HOURS PRN | 0 | 90 | UG | AEROSOLS | |||||||
| 123148834 | 12314883 | 29 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | 0 | 180 | MG | TABLET | ||||||||
| 123148834 | 12314883 | 30 | C | NEUPOGEN | FILGRASTIM | 1 | 0 | 480 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123148834 | 12314883 | 1 | Plasma cell myeloma |
| 123148834 | 12314883 | 2 | Plasma cell myeloma |
| 123148834 | 12314883 | 3 | Plasma cell myeloma |
| 123148834 | 12314883 | 4 | Depression |
| 123148834 | 12314883 | 5 | Sleep disorder therapy |
| 123148834 | 12314883 | 6 | Neuropathy peripheral |
| 123148834 | 12314883 | 7 | Bone pain |
| 123148834 | 12314883 | 8 | Bone pain |
| 123148834 | 12314883 | 9 | Bone pain |
| 123148834 | 12314883 | 10 | Asthma |
| 123148834 | 12314883 | 11 | Asthma |
| 123148834 | 12314883 | 12 | Multiple allergies |
| 123148834 | 12314883 | 13 | Neuropathy peripheral |
| 123148834 | 12314883 | 14 | Constipation |
| 123148834 | 12314883 | 15 | Abnormal faeces |
| 123148834 | 12314883 | 16 | Constipation |
| 123148834 | 12314883 | 17 | Abnormal faeces |
| 123148834 | 12314883 | 18 | Probiotic therapy |
| 123148834 | 12314883 | 20 | Neuropathy peripheral |
| 123148834 | 12314883 | 21 | Immune enhancement therapy |
| 123148834 | 12314883 | 23 | Premedication |
| 123148834 | 12314883 | 24 | Premedication |
| 123148834 | 12314883 | 25 | Premedication |
| 123148834 | 12314883 | 26 | Premedication |
| 123148834 | 12314883 | 27 | Premedication |
| 123148834 | 12314883 | 28 | Dyspnoea |
| 123148834 | 12314883 | 30 | White blood cell count |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123148834 | 12314883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123148834 | 12314883 | Back pain | |
| 123148834 | 12314883 | Burning sensation | |
| 123148834 | 12314883 | Chest pain | |
| 123148834 | 12314883 | Drug ineffective | |
| 123148834 | 12314883 | Dyspnoea | |
| 123148834 | 12314883 | Hypersensitivity | |
| 123148834 | 12314883 | Infusion related reaction | |
| 123148834 | 12314883 | Nausea | |
| 123148834 | 12314883 | Pain | |
| 123148834 | 12314883 | Pelvic pain | |
| 123148834 | 12314883 | Pharyngeal oedema | |
| 123148834 | 12314883 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 123148834 | 12314883 | 1 | 20160201 | 20160404 | 0 | |
| 123148834 | 12314883 | 2 | 20160421 | 20160630 | 0 | |
| 123148834 | 12314883 | 3 | 20150310 | 20160218 | 0 | |
| 123148834 | 12314883 | 4 | 20140801 | 0 | ||
| 123148834 | 12314883 | 5 | 20140801 | 0 | ||
| 123148834 | 12314883 | 6 | 20140801 | 0 | ||
| 123148834 | 12314883 | 7 | 20151005 | 0 | ||
| 123148834 | 12314883 | 10 | 20160201 | 0 | ||
| 123148834 | 12314883 | 13 | 20160305 | 0 | ||
| 123148834 | 12314883 | 14 | 20140801 | 0 | ||
| 123148834 | 12314883 | 15 | 20140801 | 0 | ||
| 123148834 | 12314883 | 16 | 20140801 | 0 | ||
| 123148834 | 12314883 | 17 | 20140801 | 0 | ||
| 123148834 | 12314883 | 28 | 20140801 | 0 | ||
| 123148834 | 12314883 | 29 | 20150324 | 0 | ||
| 123148834 | 12314883 | 30 | 20150311 | 20160118 | 0 |