Summary of incidence of reported adverse events possibly or probably related to Polyphenon E administration, occurring within 24 hours of Polyphenon E administration
Side effect . | National Cancer Institute grade . | Dose and dosing condition . | . | . | . | . | . | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | . | 400 mg . | . | 800 mg . | . | 1,200 mg . | . | |||||||
. | . | Fed (n = 10) . | Fasting (n = 10) . | Fed (n = 10) . | Fasting (n = 10) . | Fed (n = 10) . | Fasting (n = 10) . | |||||||
Gastrointestinal | ||||||||||||||
Nausea | 1 | 0 | 0 | 2 | 1 | 2 | 7 | |||||||
2 | 0 | 1 | 0 | 1 | 1 | 1 | ||||||||
Dyspepsia | 1 | 0 | 0 | 1 | 1 | 1 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Diarrhea | 1 | 0 | 0 | 0 | 1 | 0 | 1 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Other (gas, eructation) | 1 | 1 | 0 | 0 | 0 | 0 | 1 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Pain | ||||||||||||||
Abdominal pain | 1 | 1 | 0 | 0 | 0 | 0 | 2 | |||||||
2 | 0 | 0 | 0 | 1 | 1 | 0 | ||||||||
Headache | 1 | 0 | 1 | 2 | 2 | 1 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Neurology | ||||||||||||||
Dizziness | 1 | 0 | 0 | 1 | 0 | 0 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Dermatology | ||||||||||||||
Rash | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 1 |
Side effect . | National Cancer Institute grade . | Dose and dosing condition . | . | . | . | . | . | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | . | 400 mg . | . | 800 mg . | . | 1,200 mg . | . | |||||||
. | . | Fed (n = 10) . | Fasting (n = 10) . | Fed (n = 10) . | Fasting (n = 10) . | Fed (n = 10) . | Fasting (n = 10) . | |||||||
Gastrointestinal | ||||||||||||||
Nausea | 1 | 0 | 0 | 2 | 1 | 2 | 7 | |||||||
2 | 0 | 1 | 0 | 1 | 1 | 1 | ||||||||
Dyspepsia | 1 | 0 | 0 | 1 | 1 | 1 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Diarrhea | 1 | 0 | 0 | 0 | 1 | 0 | 1 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Other (gas, eructation) | 1 | 1 | 0 | 0 | 0 | 0 | 1 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Pain | ||||||||||||||
Abdominal pain | 1 | 1 | 0 | 0 | 0 | 0 | 2 | |||||||
2 | 0 | 0 | 0 | 1 | 1 | 0 | ||||||||
Headache | 1 | 0 | 1 | 2 | 2 | 1 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Neurology | ||||||||||||||
Dizziness | 1 | 0 | 0 | 1 | 0 | 0 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||
Dermatology | ||||||||||||||
Rash | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
2 | 0 | 0 | 0 | 0 | 0 | 1 |