Table 3.
Safety assessment and adverse event follow-up of participant.
M0 | M1 | M2 | M3 | |
---|---|---|---|---|
Liver function: alanine aminotransferase, aspartate aminotransferase, total bilirubin, albumin, globulin | √ | √ | ||
Renal function: creatinine, blood urea nitrogen, and eGFR calculated by the CKD-EPI equation | √ | √ | ||
Creatine kinase (CK), creatine kinase myocardial band (CK-MB), lactate dehydrogenase (LDH), alkaline phosphatase (ALP) | √ | √ | ||
Electrolytes: calcium (Ca), phosphorus(P), potassium(K), magnesium (Mg), sodium (Na), chloride (Cl) | √ | √ | ||
Closely follow up on the physical health after injection, and receive consultation and feedback at any time within 24 h | √ | √ | √ | √ |
Did the participant experience any adverse reactions after the injection (whether or not determined to be related to this injection) | √ | √ | √ | √ |
Digestive adverse reactions: decreased appetite, constipation or diarrhea, abdominal pain, nausea, or vomiting | √ | √ | √ | √ |
Skin adverse reactions: pruritus, allergic dermatitis, rash, swelling, and pain at the injection site | √ | √ | √ | √ |
Nervous system adverse reactions: metallic sensation in the mouth, persistent headache, convulsions, and insomnia | √ | √ | √ | √ |
Urinary adverse reactions: cloudy urine, nocturnal polyuria, and hematuria | √ | √ | √ | √ |
Skeletal system adverse reactions: bone pain and myalgia | √ | √ | √ | √ |
Respiratory and circulatory system: shortness of breath, palpitations, hypertension, shock, hypotension, and chest pain | √ | √ | √ | √ |
Hematologic and endocrine adverse reactions: rapid weight loss or gain, fever, and fear of cold | √ | √ | √ | √ |
Other adverse reactions: fatigue, asthenia, dry mouth, and fall | √ | √ | √ | √ |
Record treatment for adverse reactions (only for participants with adverse events) | √ | √ | √ | √ |
M0, baseline assessment; M1, 1 month from baseline; M2, 2 months from baseline; M3, 3 months from baseline; eGFR, estimated glomerular filtration rate; CKD-EPI, the Chronic Kidney Disease Epidemiology Collaboration equation.