Table 2.

Incdence and severity of adverse events.

	Sargramostim Phase 1a 6 μg/kg, qd, 2 mos (n = 10)		Sargramostim Phase 1b 3 μg/kg, 5d/wk, 2 mos (n = 5)		Sargramostim Phase 1b 3 μg/kg, 5d/wk, 12 mos (n = 5)
Adverse Eventa,bfor each subject	Number	Percentage	Number	Percentage	Number	Percentage
Any adverse event	10	100	5	100	5	100
Any severe adverse events	3	30	0	0	2	40
Any serious adverse events	1	10	0	0	0	0
Adverse event leading to withdrawal	4	40	0	0	0	0
Possible relationship to drug/placebo	10	100	5	100	5	100
Definitive relationship to drug/placebo	7	70	3	60	3	60
Category, Subjects reporting
1 Abnormal Laboratory	10	100	1	20	5	100
2 Injection site reaction	10	100	4	80	4	80
3 Chest pain or discomfort	4	40	1	20	1	20
4 Pain, upper torso & extremities	7	70	0	0	1	20
5 Pain, lower torso & extremities	3	30	0	0	0	0
6 Pain, other than exctremities	0	0	0	0	0	0
7 Rash, other than injection site	4	40	0	0	0	0
8 Itching, other than injection site	2	20	0	0	0	0
9 Edema, other than injection site	1	10	0	0	0	0
10 Shortness of breath, wheezing	3	30	0	0	0	0
11 Headache	2	20	1	20	1	20
12 Fatigue	2	20	0	0	0	0
13 Chills, fever	2	20	0	0	0	0
14 Infection, any	2	20	0	0	2	40
15 GI tract, nausea, vomiting	3	30	0	0	3	60
16 Muscle, soreness, weakness	3	30	1	20	2	40
17 Equilibrium	1	10	0	0	0	0
18 Inury, fall	2	20	1	20	3	60
19 Skin, not infection	1	10	0	0	1	20
20 Cardiovascular, hematological	2	20	0	0	0	0
21 Neurological, psychological, dyskinesia	2	20	1	20	2	40
22 Ophthalmological	1	10	0	0	2	40
23 Sleep anomalies	1	10	0	0	0	0
	Median	Mean ± SD	Median	Mean ± SD	Median	Mean ± SD
Total adverse events/subject	13.5	15.1 ± 8.5	3.0	3.2 ± 1.3	17.0	16.2 ± 5.5
Total adverse events/subject/mo	6.8	7.6 ± 1.2	0.25	0.27 ±0.11	1.4	1.4 ± 0.5
Severity of adverse eventsc	1.7	1.6 ± 0.3	1.0	1.2 ± 0.3	1.2	1.3 ± 0.3
Likelihood of drug-relatedc	3.75	3.5 ± 0.7	4.2	3.6 ± 1.0	3.0	2.9 ± 1.0

p < 0.05 vs Phase 1a, Mann-Whitney U test.

^aReported adverse events since the initiation of drug.

^bMore than 2 adverse advents per patient may have been reported.

^cDetemined by attending physician.