Table 3.
Characteristics of adverse events (AEs) during minocycline and placebo periods
| Minocycline | Placebo | |||||
|---|---|---|---|---|---|---|
| Category | N | % | N | % | P-value | |
| Intensity | Mild | 67 | 94 | 69 | 95 | 0.63 |
| Moderate | 4 | 6 | 3 | 4 | ||
| Severe | 0 | 0 | 1 | 1 | ||
| Drug related | Probably related | 2 | 3 | 0 | 0 | 0.93 |
| Possibly related | 66 | 93 | 66 | 90 | ||
| Not related | 3 | 4 | 7 | 10 | ||
| Resolved | No | 5 | 7 | 1 | 1 | 0.14 |
| Yes | 66 | 93 | 72 | 99 | ||
|
Adverse Event
Type |
Category | 0.38 | ||||
| Diarrhea/Loose stools | 15 | 21 | 15 | 21 | ||
| GI upset/Vomiting/Loss of appetite | 9 | 13 | 15 | 21 | ||
| Skin Rash/Itching/Swelling | 12 | 17 | 7 | 10 | ||
| Fever/Chills/URI symptoms/Sore throat | 6 | 8 | 11 | 15 | ||
| Ear infection | 0 | 0 | 2 | 3 | ||
| Fungal skin infection | 1 | 1 | 1 | 1 | ||
| Headache | 4 | 6 | 5 | 7 | ||
| Sunburn/Sun sensitivity | 4 | 6 | 1 | 1 | ||
| Drowsiness | 2 | 3 | 3 | 4 | ||
| Increased agitation, aggression, tantrums, uncooperative, irritability |
1 | 1 | 4 | 5 | ||
| Blue-grey/Grey hue to teeth or other tissues |
3 | 4 | 1 | 1 | ||
| Yellowish teeth | 3 | 4 | 0 | 0 | ||
| Brownish teeth | 2 | 3 | 0 | 0 | ||
| Dark colored urine/Changes in urination | 1 | 1 | 2 | 3 | ||
| Increased appetite | 2 | 3 | 1 | 1 | ||
| Trouble sleeping | 2 | 3 | 0 | 0 | ||
| Seizure/Staring spell | 1 | 1 | 1 | 1 | ||
| Dizziness/Unsteadiness | 0 | 0 | 1 | 1 | ||
| Masturbation | 1 | 1 | 0 | 0 | ||
| Right leg pain | 1 | 1 | 0 | 0 | ||
| Constipation | 1 | 1 | 1 | 1 | ||
| Sneezing, itchy eyes | 0 | 0 | 1 | 1 | ||
| PE tubes removed | 0 | 0 | 1 | 1 | ||