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Table 2 Characterizations of adverse events

From: Treatment of multiple system atrophy using intravenous immunoglobulin

 

Type

No

Subjects

R

Comments

1

Elevated BP

7

7

I

Transient, responding to adjusting the infusion rate

2

Accidental injury

1

1

N

After It4, nose fracture

3

UTI

1

1

N

After It5, treated with antibiotics

4

Pruritic skin rash

4

3

I

2 subjects withdrew from the study. In these subjects, one subject experienced rash after It1 and second after It2. 1 subject experienced rash after I4 and I5 and was treated with Diphenhydramine, Acetaminophen and oral Prednisone

5

Increased temperature and/or skin flushing

5

1

I

Treated with Diphenhydramine, Acetaminophen, and slowing the infusion rate

6

RLS

1

1

N

Diagnosed after It4, treated with iron supplements

8

Decreased GFR

1

2

N

After It5 and It6, resolved

9

Ankle edema

1

 

N

After It5, treated with diazide diuretics

10

Elevated BUN

1

1

N

After It5, started trial with elevated BUN at screening visit, resolved

11

Worsening of allergies

2

1

N

Worsening of running nose and cough after It5 and It6, also associated with cold and fever after It6, treated with Acetaminophen, Pseudoephedrine, and Diphenhydramine.

13

Nodular lung abnormality

1

1

N

Later determined to be abnormal tangle of veins, probably since birth

14

Low potassium

1

1

P

After It1, treated with increased dose of potassium

15

GI viral infection

1

1

N

After It5, treated with fluids, antiemetics and anti-diarrheal agents

16

Elevated PSA

1

1

N

Before It1, resolved

17

Wrist strain

1

1

N

After It1, resolved

18

Worsening of sleep apnea

1

1

N

After It2, prrescribed CPAP

  1. Legends: UTI=urinary tract infection, BUN=blood urea nitrogen, GFR=glomerular filtration rate, PSA=prostate specific antigen, CPAP=continuous positive airway pressure. R= relationship of the AE to the study drug, N= not related, PR=possibly related, I=infusional AE. It1-6 designates the infusion treatment 1–6.