Please read the following Adverse Events Scenario before attempting the questions:
A patient in a clinical trial suffers an adverse event. The study is as follows: the active treatment period is 6 weeks and then the patient stops taking medication. There is follow up for an additional 3 months which involves a telephone call from the study team every 2 weeks. This is the sequence of events relating to the adverse event:
Day 1: Entry to the study and start of treatment
Day 9: The patient slips on ice and suffers a broken arm and a substantial grazes to their right knee. The patient attends A&E, has the arm X-rayed and set, the knee cleaned and dressed and returns home the same day.
Day 14: the patient attends for a study visit and complains of pain in the broken arm and the knee has become infected. The patient is prescribed analgesics and the knee is cleaned and redressed.
Day 17: the patient is admitted to hospital with a severe local infection in the knee wound. The patient is prescribed IV antibiotics.
Day 19: the infection has not responded to the antibiotics, has become systemic and is now life-threatening. Broad spectrum antibiotics are prescribed. The patient is unconscious.
Day 21: the patient begins to improve.
Day 26: the patient is discharged and goes home.
Day 27: the patient should have attended for a study visit but does not attend because they are still feeling unwell.
Day 29: the patient attends for a rescheduled study visit and says they feel much better. The knee wound is healing and the arm is less painful.
Day 42: Final Study visit – the arm is feeling fine but the cast is itchy. The knee wound is not yet fully healed, but is much improved.
Based on lab test results the investigator thinks it possible that the IMP may have compromised the patient's immune system and this has exacerbated the infection. This has not previously been reported with this product.