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 |