Table 2.
Observed adverse events.
| Patient | Adverse Event | DLT | Severity | SAE | Relationship | Measure 1 | Measure 2 | Outcome |
|---|---|---|---|---|---|---|---|---|
| 001 | transient chest pain(2-3S) | NO | 1 | NO | 4 | 2 | 1 | 1 |
| abdominal distension | NO | 1 | NO | 3 | 2 | 1 | 1 | |
| weakness | NO | 1 | NO | 4 | 2 | 1 | 3 | |
| abdominal distension worsened | NO | 2 | NO | 4 | 6 | 1 | 3 | |
| waist up worsened | NO | 2 | NO | 4 | 6 | 1 | 3 | |
| pelvic pain worsened | NO | 2 | NO | 4 | 6 | 1 | 3 | |
| abdominal burning sensation | NO | 2 | NO | 4 | 6 | 1 | 3 | |
| nausea | NO | 1 | NO | 4 | 6 | 2 | 3 | |
| vomiting | NO | 1 | NO | 4 | 6 | 2 | 3 | |
| weak | NO | 2 | NO | 2 | 2 | 1 | 1 | |
| 002 | herpes simplex | NO | 1 | NO | 4 | 2 | 2 | 1 |
| lymphocytopenia | NO | 1 | NO | 3 | 2 | 1 | 1 | |
| elevated urine bacteria | NO | 1 | NO | 4 | 2 | 1 | 1 | |
| weakness | NO | 1 | NO | 2 | 2 | 1 | 1 | |
| elevated urine bacteria | NO | 1 | NO | 4 | 2 | 1 | 1 | |
| elevated urinary leukocyte | NO | 1 | NO | 4 | 2 | 1 | 1 | |
| fever | NO | 1 | NO | 3 | 2 | 1 | 1 | |
| abdominal pain | NO | 1 | NO | 4 | 6 | 1 | 1 | |
| 003 | noninfectious diarrhea | NO | 1 | NO | 4 | 2 | 2 | 1 |
(DLT and SAE were not observed).
DLT, dose limiting toxicity.
Severity: 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4; 5=Grade 5.
SAE, severe adverse event.
Relationship, the relationship with research drugs. 1=yes; 2=may be 2; 3=may not be; 4=sure not be; 5= unable to determine.
Measure 1: Measures taken with respect to experimental drugs. 1=dose increase; 2= same dose; 3=dose decrease; 4=suspended medication; 5= termination of medication; 6= inapplicability; 7=unknown.
Measure 2: Measures taken with respect to patients. 1=none; 2=drug combination; 3=therapy combination; 4=quit the test; 5=others.
Outcome: 1=recovery/cure; 2=recovery/cure with sequelae; 3=recovering/improving; 4=quit the test; 5=others.