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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116555495 | 11655549 | 5 | F | 201204 | 20160808 | 20151023 | 20160902 | PER | US-PFIZER INC-2015340123 | PFIZER | 3.00 | YR | M | Y | 15.87000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116555495 | 11655549 | 1 | PS | RAPAMUNE | SIROLIMUS | 1 | Oral | 3 ML, DAILY | 7398216 | 21083 | 3 | ML | ORAL SOLUTION | ||||||
| 116555495 | 11655549 | 2 | SS | RAPAMUNE | SIROLIMUS | 1 | UNK | 7398217 | 21083 | ORAL SOLUTION | |||||||||
| 116555495 | 11655549 | 3 | SS | RAPAMUNE | SIROLIMUS | 1 | Oral | 1 MG, UNK | 21083 | 1 | MG | ORAL SOLUTION | |||||||
| 116555495 | 11655549 | 4 | SS | RAPAMUNE | SIROLIMUS | 1 | Oral | 3.5 MG, 1X/DAY | 21083 | 3.5 | MG | ORAL SOLUTION | QD | ||||||
| 116555495 | 11655549 | 5 | SS | RAPAMUNE | SIROLIMUS | 1 | Oral | 3.5 ML, DAILY | 21083 | 3.5 | ML | ORAL SOLUTION | |||||||
| 116555495 | 11655549 | 6 | SS | RAPAMUNE | SIROLIMUS | 1 | Oral | 3.5 MG, 1X/DAY | 13122902 | 21083 | 3.5 | MG | ORAL SOLUTION | QD | |||||
| 116555495 | 11655549 | 7 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Oral | 750 MG, DAILY, 450 MG AM, 300 MG PM, (300MG IN THE MORNING AND 450 IN THE EVENING) | 0 | 750 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116555495 | 11655549 | 1 | Cerebral disorder |
| 116555495 | 11655549 | 2 | Gene mutation |
| 116555495 | 11655549 | 3 | Neurodevelopmental disorder |
| 116555495 | 11655549 | 4 | Polyhydramnios |
| 116555495 | 11655549 | 5 | Epilepsy |
| 116555495 | 11655549 | 6 | Premature baby |
| 116555495 | 11655549 | 7 | Seizure |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116555495 | 11655549 | Drug level decreased | |
| 116555495 | 11655549 | Fungal skin infection | |
| 116555495 | 11655549 | Impaired healing | |
| 116555495 | 11655549 | Product use issue | |
| 116555495 | 11655549 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 116555495 | 11655549 | 4 | 201604 | 0 | ||
| 116555495 | 11655549 | 6 | 201204 | 0 | ||
| 116555495 | 11655549 | 7 | 201307 | 0 |