Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome)
Table 9
(a) Comparison of ADRs (top 10) between SFI and placebo groups
ADR
SFI (n=78)
Placebo (n=79)
All (n=157)
Chills
1 (1.28%)
0 (0.00%)
1 (0.64%)
Erythra
1 (1.28%)
0 (0.00%)
1 (0.64%)
Total
2 (2.56%)
0 (0.00%)
2 (1.27%)
(b) Accessory: list of ADRs
Subject number
Group
ADR symptom
ADR description
006002
SFI
Chill
Chill occurred after injection of 10 ml SFI.
010070
SFI
Erythra
The subject felt itchy skin after 1 day of medication. Skin flushing was seen on the upper parts of the chest and abdomen, the medial buttocks, and both lower limbs. There was scratch, but no break.