Table 3.
Adverse Events
| Adverse Event | TwHF Group | Sulfasalazine Group | P Value* | ||
|---|---|---|---|---|---|
| All Patients (n = 60) |
Patients Who Withdrew (n = 7) |
All Patients (n = 61) |
Patients Who Withdrew (n = 17) |
||
| Total events, n (%) | |||||
| Any event | 53 (88.3) | 55 (90.2) | 0.78 | ||
| Related to study drug† | 34 (56.7) | 37 (60.7) | 0.71 | ||
| Serious adverse events‡ | 3 (5) | 7 (11.5) | 4 | 0.32 | |
| Most frequent adverse events, n (%)§ | |||||
| Gastrointestinal adverse events | |||||
| Nausea | 13 (22) | 3‖ | 21 (34) | 4 | 0.157 |
| Vomiting | 9 (15) | 1‖ | 9 (15) | 1 | 1.00 |
| Diarrhea | 15 (25) | 1 | 11 (18) | 0.38 | |
| Constipation | 5 (8) | 8 (13) | 0.56 | ||
| Dyspepsia | 13 (22) | 1 | 5 (8) | 0.044 | |
| Abdominal distention | 6 (10) | 1‖ | 2 (3) | 0.163 | |
| Abdominal pain | 11 (18) | 6 (10) | 0.20 | ||
| Gastroenteritis | 0 (0) | 4 (7) | 0.119 | ||
| Infectious adverse events | |||||
| Upper respiratory tract infection | 11 (18) | 6 (10) | 0.20 | ||
| Influenza | 2 (3) | 4 (7) | 0.68 | ||
| Pneumonia | 1 (2) | 0 (0) | 0.50 | ||
| Urinary tract infection | 2 (3) | 6 (10) | 0.27 | ||
| Other infections¶ | 2 (3) | 7 (11) | 1 | 0.163 | |
| Other adverse events | |||||
| Headache | 5 (8) | 13 (21) | 0.072 | ||
| Rash | 7 (12) | 7 (11) | 7 | 1.00 | |
| Fatigue | 5 (8) | 1‖ | 10 (16) | 0.27 | |
| Peripheral edema | 4 (7) | 3 (5) | 0.72 | ||
| Cough | 4 (7) | 2 (3) | 0.44 | ||
| Hypertension | 2 (3) | 4 (7) | 0.68 | ||
| Hypercholesterolemia | 4 (7) | 1 (2) | 0.21 | ||
| Blurred vision | 4 (7) | 0 (0) | 0.057 | ||
| Hot flush | 3 (5) | 2 (3) | 0.68 | ||
| Amenorrhea | 3 (5) | 1 (2) | 0.37 | ||
| Dry mouth | 3 (5) | 0 (0) | 0.119 | ||
| Anemia | 0 (0) | 5 (8) | 0.057 | ||
| Chest pain | 3 (5) | 1 (2) | 0.37 | ||
| Myocardial infarction | 0 (0) | 1 (2) | 1.00 | ||
| Deep venous thrombosis | 1 (2) | 0 (0) | 0.50 | ||
| Thrombocytopenia | 2 (3) | 1 | 0 (0) | 0.24 | |
| Neutropenia | 1 (2) | 0 (0) | 0.50 | ||
| ECG changes on study | 4 (7) | 5 (8) | 0.98 | ||
ECG = electrocardiography; TwHF = Tripterygium wilfordii Hook F.
*
Based on the Fisher exact test.
†
None of the serious adverse events were thought to be related to study drug (see Appendix Table 3, available at www.annals.org, for list of serious adverse events).
‡
Frequency ≥5% in either treatment group, except for infections and cardiac, hematologic, and hepatic events, which were included independent of frequency.
§
Determined by the site physician.
‖
Patient had both events as reasons for withdrawal.
¶
Included fungal infection (2 events) and 1 event each of cellulitis, herpes zoster infection, oral candidiasis, otitis externa, postoperative infection, tooth abscess, and viral infection.