Table 2.
Attribution of AE to Study Medication | Total | |||||||
---|---|---|---|---|---|---|---|---|
Possible | Unlikely* | Unrelated** | ||||||
Minocycline | Placebo | Minocycline | Placebo | Minocycline | Placebo | |||
CTCAE grade, N1 | 1 | 0 | 0 | 1 | 2 | 1 | 5 | 9 |
2 | 0 | 0 | 13 | 9 | 3 | 4 | 29 | |
3 | 0 | 0 | 3 | 2 | 2 | 5 | 12 | |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Total, N | 0 | 0 | 17 | 13 | 6 | 14 | 50 |
Number of events
Grade 1 unlikely AEs include dermatitis, fever and weight loss.
Grade 2 unlikely AEs include anorexia, dehydration, diarrhea, dysgeusia, dysphagia, dyspnea, erythema, esophagitis, esophagtis, fatigue, fever, and odynophagia
Grade 3 unlikely AEs include cough, dehydration, dermatitis, dysphagia, and dyspnea.
Grade 1 unrelated AEs include alopecia, dermatitis, erythema, high bilirubin, and odynophagia.
Grade 2 unrelated AEs include AST increased, diarrhea, esophagitis, fatigue, odynophagia, rectal bleeding, and vomiting.
Grade 3 unrelated AEs include dehydration, dysphagia, dyspnea, nausea, pain in extremity, and pulmonary embolism
CTCAE, Common Terminology Criteria for Adverse Events version 3