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In clinical trials involving a total of 1436 patients, adverse experiences from all causalities were monitored across treatment groups.

In the Circulatory System category, 10 subjects (1.6%) in the ATRIDOX (doxycycline hyclate) ® group were reported as having “unspecified essential hypertension.” Only 1 subject (0.2%) in the Vehicle group, and none in the Scaling and Root Planing or Oral Hygiene groups were reported to have “unspecified essential hypertension.” In all cases, the event occurred anywhere from 13 to 134 days post treatment. There is no known association of oral administration of doxycycline with essential hypertension.

Two patients in the polymer vehicle group and none in the ATRIDOX (doxycycline hyclate) ® group (0.2% for both groups combined) reported adverse events consistent with a localized allergic response.

Sex, age, race and smoking status did not appear to be correlated with adverse events.

The following table lists the incidence of treatment-emergent adverse events from all causalities, across all treatment groups, occurring in ≥ 1% of the entire study population.

Body System Verbatim Terms Doxycycline
n=609
Vehicle
n=413
OH
n=204
SRP
n=210
Circulatory
  High blood pressure 1.60% 0.20% 0.00% 0.00%
Digestive
  Gum discomfort, pain or soreness; loss of attachment; increased pocket depth 18.10% 23.00% 20.10% 21.00%
  Toothache, pressure sensitivity 14.30% 14.30% 10.30% 18.10%
  Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration 9.90% 10.90% 10.30% 8.60%
  Thermal tooth sensitivity 7.70% 8.50% 4.40% 6.70%
  Gum inflammation, swelling, sensitivity 4.10% 5.80% 5.40% 5.70%
  Soft tissue erythema, sore mouth, unspecified pain 4.30% 5.30% 2.70% 6.20%
  Indigestion, upset stomach, stomachache 3.60% 4.10% 2.90% 3.80%
  Diarrhea 3.30% 2.40% 1.00% 1.00%
  Tooth mobility, bone loss 2.00% 0.70% 0.50% 2.40%
  Periapical abscess, lesion 1.50% 1.90% 1.00% 0.50%
  Aphthous ulcer, canker sores 0.70% 1.70% 1.00% 1.40%
  Fistula 0.80% 1.50% 1.50% 1.00%
  Endodontic abscess, pulpitis 1.50% 1.50% 0.00% 0.50%
  Jaw pain 1.10% 0.50% 1.00% 1.90%
  Tooth loss 0.80% 1.50% 1.50% 0.00%
  Bleeding gums 1.00% 0.70% 0.00% 2.40%
Genitourinary
  Premenstrual tension syndrome 4.40% 3.10% 2.50% 3.30%
Ill-Defined Conditions
  Headache 27.30% 28.10% 23.50% 23.80%
  Cough 3.60% 6.10% 2.90% 2.40%
  Sleeplessness 3.40% 1.50% 2.00% 2.90%
  Body aches, soreness 1.60% 1.20% 1.50% 1.40%
  Nausea and vomiting 1.80% 0.70% 2.50% 0.50%
  Fever 1.00% 1.90% 1.00% 1.90%
Injury & Poisoning
  Broken tooth 5.10% 4.10% 4.90% 5.70%
Mental
  Tension headache 1.80% 0.70% 0.00% 1.00%
Musculoskeletal
  Muscle aches 6.40% 4.60% 4.90% 3.30%
  Backache 3.60% 5.30% 2.50% 6.20%
  Pain in arms or legs 1.50% 2.20% 2.00% 2.40%
  Lower back pain 1.60% 1.70% 0.50% 2.90%
  Neck pain 1.30% 1.70% 1.00% 1.90%
  Shoulder pain 1.00% 1.00% 1.50% 1.00%
Nervous System
  Ear infection 1.60% 1.90% 2.00% 0.00%
Respiratory 
  Common cold 25.50% 25.20% 18.10% 16.70%
  Flu, respiratory 6.10% 9.00% 3.90% 6.70%
  Stuffy head, post nasal drip, congestion 5.60% 7.70% 2.90% 4.80%
  Sore throat 5.70% 6.50% 2.00% 3.30%
  Sinus infection 5.30% 2.70% 1.00% 1.90%
  Flu 2.80% 2.90% 2.90% 3.30%
  Bronchitis 2.30% 1.90% 1.50% 1.00%
  Allergies 1.00% 1.00% 1.00% 1.90%
Skin & Subcutaneous Tissue
  Skin infection or inflammation 1.30% 1.00% 1.00% 1.00%