. 2023 May 22;12:26. doi: 10.1186/s40035-023-00361-1

Table 2.

Incidence, severity, and relationship of adverse events to treatment

Adverse events^a,b for each subject	Sargramostim Phase 1b 3 μg/kg, q5d, 33 months (n = 5)
Adverse events^a,b for each subject	Number	Percentage	Treatment-related likelihood^c
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	na^d
6 Pain, other than extremities	1	20	4.0 ± 0.0
7 Rash, other than injection site	0	0	na^d
8 Itching, other than injection site	0	0	na^d
9 Edema, other than injection site	0	0	na^d
10 Shortness of breath, wheezing	0	0	na^d
11 Headache	1	20	3.0 ± 0.0
12 Fatigue	0	0	na^d
13 Chills, fever	0	0	na^d
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	na^d
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 events^c	1.05	1.16 ± 0.20
Likelihood of related to treatment^c	2.89	2.78 ± 1.02

^aReported adverse events since the initiation of drug

^bMore than 2 adverse events per patient may have been reported

^cDetermined by physician (1 = Unrelated, 2 = Unlikely, 3 = Possible, 4 = Probable, 5 = Definite)

^dna = not applicable