Patients treated with Kesimpta

Prospective observational cohort study. There was no treatment allocation.

An adverse event (AE) is any untoward medical occurrence experienced by a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not related to the medicinal product(s).

A SAE is defined as an adverse event which:

• Is fatal or life-threatening

• Results in persistent or significant disability/incapacity

• Constitutes a congenital anomaly/birth defect

• Requires inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization is for:

  • Routine treatment or monitoring of the indication under study, not associated with any deterioration in condition
  • Elective or pre-planned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of treatment with Kesimpta
  • Social reasons and respite care in the absence of any deterioration in the patient's general condition

• Is medically significant, i.e., events that jeopardize the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.

An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Kesimpta or whose causality is not recorded.

The investigator comprehensively assessed the symptom changes in relapsing-remitting Multiple Sclerosis (MS) and active Secondary Progressive Multiple Sclerosis (SPMS), rating the changes as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of this drug, and record the results in the Case report forms (CRFs).