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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127028581 | 12702858 | 1 | I | 20160823 | 20160831 | 20160831 | EXP | MZ-VIIV HEALTHCARE LIMITED-MZ2016GSK126089 | VIIV | WINGI O, CAPPELLESSO R, AREGO R, CUPPINI E, MUHELO A, PUTOTO G ET AL. FAILED CONSERVATIVE MANAGEMENT OF A CASE OF APLASIA CUTIS CONGENITA IN A LOW-INCOME COUNTRY. CLINICAL CASE REPORTS. 2016;4 (8):756-758 | 0.00 | N | F | Y | 0.00000 | 20160831 | OT | MZ | MZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127028581 | 12702858 | 1 | PS | LAMIVUDINE. | LAMIVUDINE | 1 | Transplacental | 300 MG, UNK | U | 20564 | 300 | MG | |||||||
| 127028581 | 12702858 | 2 | SS | TENOFOVIR DISOPROXIL FUMARATE. | TENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 300 MG, UNK | U | 0 | 300 | MG | |||||||
| 127028581 | 12702858 | 3 | SS | Efavirenz | EFAVIRENZ | 1 | Transplacental | 600 MG, UNK | U | 0 | 600 | MG | |||||||
| 127028581 | 12702858 | 4 | SS | GENTAMICIN. | GENTAMICIN | 1 | 6 MG, QD | U | 0 | 6 | MG | QD | |||||||
| 127028581 | 12702858 | 5 | SS | Azidothymidine | ZIDOVUDINE | 1 | 0.5 ML, BID | U | 0 | .5 | ML | BID | |||||||
| 127028581 | 12702858 | 6 | SS | Paracetamol | ACETAMINOPHEN | 1 | 15 MG, TID (EVERY 8 HOURS) | U | 0 | 15 | MG | TID | |||||||
| 127028581 | 12702858 | 7 | SS | SILVER SULFADIAZINE. | SILVER SULFADIAZINE | 1 | Topical | SILVER SULFADIAZINE DRESSING | U | 0 | |||||||||
| 127028581 | 12702858 | 8 | SS | Vancomycin | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 15 MG, SINGLE | U | 0 | 15 | MG | |||||||
| 127028581 | 12702858 | 9 | SS | Vancomycin | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 10 MG, BID (EVERY 12 H) | U | 0 | 10 | MG | BID | ||||||
| 127028581 | 12702858 | 10 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | 6 MG, EVERY 72 H | U | 0 | 6 | MG | ||||||||
| 127028581 | 12702858 | 11 | SS | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | 30 MG, BID (EVERY 12 H) | U | 0 | 30 | MG | BID | |||||||
| 127028581 | 12702858 | 12 | SS | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | 70 MG FOR 12 H | U | 0 | 70 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127028581 | 12702858 | 1 | Antiretroviral therapy |
| 127028581 | 12702858 | 2 | Antiretroviral therapy |
| 127028581 | 12702858 | 3 | Antiretroviral therapy |
| 127028581 | 12702858 | 4 | Aplasia cutis congenita |
| 127028581 | 12702858 | 5 | Product used for unknown indication |
| 127028581 | 12702858 | 6 | Pain |
| 127028581 | 12702858 | 7 | Skin lesion |
| 127028581 | 12702858 | 8 | Product used for unknown indication |
| 127028581 | 12702858 | 10 | Product used for unknown indication |
| 127028581 | 12702858 | 11 | Product used for unknown indication |
| 127028581 | 12702858 | 12 | Aplasia cutis congenita |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127028581 | 12702858 | OT |
| 127028581 | 12702858 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127028581 | 12702858 | Abdominal distension | |
| 127028581 | 12702858 | Aplasia cutis congenita | |
| 127028581 | 12702858 | Condition aggravated | |
| 127028581 | 12702858 | Contraindication to medical treatment | |
| 127028581 | 12702858 | Fistula | |
| 127028581 | 12702858 | Foetal exposure during pregnancy | |
| 127028581 | 12702858 | Irritability | |
| 127028581 | 12702858 | Laceration | |
| 127028581 | 12702858 | Necrosis | |
| 127028581 | 12702858 | Pain | |
| 127028581 | 12702858 | Selective eating disorder | |
| 127028581 | 12702858 | Skin disorder | |
| 127028581 | 12702858 | Skin exfoliation | |
| 127028581 | 12702858 | Skin lesion | |
| 127028581 | 12702858 | Skin necrosis | |
| 127028581 | 12702858 | Treatment failure | |
| 127028581 | 12702858 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |