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Table 2 Incidence, severity, and relationship of adverse events to treatment

From: An open-label multiyear study of sargramostim-treated Parkinson’s disease patients examining drug safety, tolerability, and immune biomarkers from limited case numbers

Adverse eventsa,b for each subject

Sargramostim Phase 1b

3 μg/kg, q5d, 33 months (n = 5)

Number

Percentage

Treatment-related likelihoodc

Any adverse event

5

100

 

Any severe adverse events

1

20

 

Any serious adverse events

1

20

 

Adverse event leading to withdrawal

0

0

 

Possible relationship to drug/placebo

5

100

 

Definitive relationship to drug/placebo

3

60

 

Category, Subjects reporting

  

Mean ± SD

1 Abnormal Laboratory

5

100

3.7 ± 0.9

2 Injection site reaction

4

80

4.4 ± 1.1

3 Chest pain or discomfort

1

20

2.0 ± 1.4

4 Pain, upper torso & extremities

1

20

4.0 ± 0.0

5 Pain, lower torso & extremities

0

0

nad

6 Pain, other than extremities

1

20

4.0 ± 0.0

7 Rash, other than injection site

0

0

nad

8 Itching, other than injection site

0

0

nad

9 Edema, other than injection site

0

0

nad

10 Shortness of breath, wheezing

0

0

nad

11 Headache

1

20

3.0 ± 0.0

12 Fatigue

0

0

nad

13 Chills, fever

0

0

nad

14 Infection, any

2

40

1.0 ± 0.0

15 GI tract, nausea, vomiting

3

60

1.0 ± 0.0

16 Muscle, soreness, weakness

2

40

2.3 ± 1.2

17 Equilibrium

0

0

nad

18 Injury, fall

3

60

1.1 ± 0.3

19 Skin, not infection

4

80

3.3 ± 1.2

20 Cardiovascular, hematological

1

20

2.0 ± 0.0

21 Neurological, psychological, dyskinesia

3

60

1.0 ± 0.0

22 Ophthalmological

3

60

1.0 ± 0.0

23 Sleep anomalies

1

20

2.0 ± 1.4

24 Neoplasms, cysts

1

20

1.0 ± 0.0

25 Weight loss

1

20

1.0 ± 0.0

 

Median

Mean ± SD

 

Total adverse events/subject

25.00

39.80 ± 27.73

 

Total adverse events/subject per month

1.08

1.42 ± 0.99

 

Severity of adverse eventsc

1.05

1.16 ± 0.20

 

Likelihood of related to treatmentc

2.89

2.78 ± 1.02

 
  1. aReported adverse events since the initiation of drug
  2. bMore than 2 adverse events per patient may have been reported
  3. cDetermined by physician (1 = Unrelated, 2 = Unlikely, 3 = Possible, 4 = Probable, 5 = Definite)
  4. dna = not applicable