Melden van SAE/AEs

Werkwijze onderzoeker op de trialsites:

Serious adverse events (SAEs)

· De lokale (hoofd)onderzoeker meldt alle SAEs binnen 24 uur na het ontdekken van het event aan de sponsor (approach@hagaziekenhuis.nl).

· SAEs in de vorm van opnames vanwege luchtweginfecties of bronchiale hyperreactiviteit, moeten binnen 2 weken gemeld worden bij de sponsor.

· De lokale (hoofd)onderzoeker stuurt een gedetailleerd SAE rapport naar de sponsor en verzorgt de extra documenten indien de sponsor of METC daarom vraagt.

Adverse Events (AEs)

· Elke AE en AR (adverse reaction) wordt bijgehouden in het elektronisch patiëntendossier en op de daarvoor bestemde CRFs.

Suspected unexpected serious adverse reactions (SUSARs)

· Meldt de SUSAR aan de sponsor direct nadat deze bij de locale onderzoeker bekend werd.

Werkwijze van de sponsor/hoofdonderzoekers staat beschreven in de SOP.

Definities

Conform onderzoeksprotocol v3 dd 24-04-2018

Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded.

A serious adverse event (SAE) is any untoward medical occurrence or effect that

- results in death;

- is life threatening (at the time of the event);

- requires hospitalisation or prolongation of existing inpatients’ hospitalisation;

- results in persistent or significant disability or incapacity;

- is a congenital anomaly or birth defect; or

- any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator.

An elective hospital admission will not be considered as a serious adverse event.

Mild AEs and ARs are: nausea or vomiting (1:10), diarrhea, glossitis or stomatitis (1:1,000-10,000), (erythematous) rash, pruritus or mild headache (incidence not known, in the PSC mentioned as mild and mostly reversible). These mild AEs do not require immediate report or discontinuation during this study.

Severe adverse reactions (SARs) to the medical investigational product (co-trimoxazole) are: hematologic changes as leucopenia, neutropenia, thrombopenia, granulocytopenia (1:1,000-10,000), anaphylactic reaction (<1:10,000), hyperkalemia (<1:10,000), convulsions (<1:10,000), interstitial nephritis or reduced renal function (incidence unknown), toxic epidermal necrolysis (<1:10,000), Stephen-Johnson syndrome (<1:10,000), Henoch-Schönlein purpura (HSP) (<1:10,000), DRESS syndrome (<1:10,000).

Deze tekst is gebaseerd op de SOP Werkwijze melden SAE en AE v1 dd 14-01-2019