Relationship between SAEs and NTZ treatment Severity ... - PLOS

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recovered stopped permanently. Retinal detachment. (N = 1) unknown unknown recovered with sequelae no action taken. Sinus tachycardia (N = 1) unrelated.


Multiple sclerosis relapses (N = 14)

Cardiac disorders (N = 5)

Infections (N = 2) Neurological disorders (N = 3)

PML (N = 3)

Relationship between SAEs and NTZ treatment

Severity

Impact on NTZ treament

unknown unknown unknown severe severe severe unknown unknown unknown severe unknown unknown

recovered with sequelae not recovered recovered recovered recovered recovered with sequelae recovered recovered with sequelae not recovered recovered recovered recovered recovered with sequelae unknown recovered recovered recovered recovered with sequelae recovered with sequelae not recovered recovered with sequelae not recovered not recovered recovered not recovered not recovered recovered with sequelae recovered with sequelae not recovered not recovered recovered recovered not recovered recovered recovered unknown not recovered recovered not recovered

moderate

recovered

moderate severe

not recovered no action taken recovered no action taken

unrelated unrelated unrelated unrelated unrelated

severe severe moderate moderate moderate

unrelated unrelated

moderate mild

unrelated unrelated unrelated unrelated unrelated

mild mild unknown unknown unknown

unrelated unknown related related unrelated

unknown unknown severe severe severe

unrelated

severe

unrelated unrelated

severe unknown

unknown related unrelated unknown related related

moderate unknown mild unknown severe moderate

related

unknown

Immune reconstitution related inflammatory syndrome related (N = 3) unknown related Allergic reactions (N = 2) unknown unknown Neoplasms (N = 2) unknown Pregnancy complications unknown (N = 2) unknown Progression of multiple related sclerosis (N = 2) unrelated Acute renal failure (N = 1) unrelated Autonomic dysfunction (N = 1) related Depressive symptom aggravated (N = 1) unrelated Femoral neck fracture unrelated

Outcome

no action taken stopped temporarily stopped temporarily stopped temporarily withdrawn no action taken no action taken stopped permanently stopped temporarily no action taken no action taken no action taken no action taken stopped temporarily stopped permanently stopped permanently stopped permanently no action taken no action taken stopped permanently stopped temporarily withdrawn stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped permanently stopped temporarily stopped permanently no action taken withdrawn withdrawn no action taken stopped permanently stopped permanently

(N = 1) Hypoxic brain damage (N = 1) unrelated Postoperative bleeding (N = 1) unrelated Retinal detachment (N = 1) unknown Sinus tachycardia (N = 1)

unrelated

with sequelae severe

fatal

severe

recovered stopped permanently recovered with sequelae no action taken recovered with sequelae no action taken

unknown severe

stopped permanently