Table 4. Adverse Events.
Attribution | Dexamethasone a | Placebo b | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Days 1-7 | Days 8+ | Days 1-7 | Days 8+ | |||||||||
| ||||||||||||
G1 | G2 | G3 | G1 | G2 | G3 | G1 | G2 | G3 | G1 | G2 | G3 | |
Possible | 2 | 2 | 0 | 1 | 0 | 0 | 7 | 3 | 1 | 2 | 3 | 2 |
Probable | 3 | 4 | 0 | 3 | 0 | 0 | 3 | 3 | 0 | 4 | 2 | 0 |
Unlikely | 2 | 2 | 0 | 1 | 0 | 0 | 8 | 0 | 0 | 2 | 1 | 0 |
Unrelated | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| ||||||||||||
Total | 7 | 9 | 0 | 5 | 0 | 0 | 19 | 6 | 1 | 8 | 6 | 2 |
The possible/probable grade 1 and 2 events in the dexamethasone arm were as follows: anxiety/irritability (n=2), diarrhea (n=1), dyspepsia (n=1), halitosis (n=1) edema (n=3), hiccups (n=1), hot flashes (n=1), hyperglycemia (n=1), hyperhidrosis (n=1), insomnia (n=2) and myalgia (n=1).
The possible/probable grade 1 and 2 events in the placebo arm included blurred vision (n=2), dyspepsia (n=2), edema (n=1), fatigue (n=3), flashing (n=1), mouth sores (n=1), taste changes (n=1), hyperglycemia (n=1), fever (n=1), insomnia (n=4), myalgia (n=1), nausea/vomiting (n=4), pain (n=2), rash (n=1) and sore throat (n=1). The grade 3 events in the placebo arm were gastric hemorrhage/ulcer (n=2) and insomnia (n=1).