p; 6 4
Abscess 2 2
Asthenia 3 2
Headache 6 7
Infection 7 5
Cardiovascular System
Phlebitis 3 4
Digestive System
Diarrhea 12 11
Dyspepsia 2 2
Nausea 26 13
Vomiting 18 9
Hemic and Lymphatic System
Anemia 5 6
Metabolic and Nutritional
Alkaline Phosphatase
Increased 3 3
Amylase Increased 3 2
Bilirubinemia 2 1
BUN Increased 3 1
Healing Abnormal 3 2
Hyponatremia 2 1
Hypoproteinemia 5 3
SGOT Increasedb 4 5
SGPT Increasedb 5 5
Respiratory System
Pneumonia 2 2
Nervous System
Dizziness 3 3
Skin and Appendages
Rash 3 4
Table 2. Patients with Outcome of Death by Infection Type TYGACIL Comparator Risk Difference*
Infection Type n/N % n/N % % (95% CI)
CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI = Complicated skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP = Ventilator-associated pneumonia; RP = Resistant pathogens; DFI = Diabetic foot infections.* The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. The 95% CI for each infection type was calculated using the normal approximation method without continuity correction. ** Overall adjusted (random effects model by trial weight) risk difference estimate and 95% CI. a These are subgroups of the HAP population. Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis).
cSSSI 12/834 1.4 6/813 0.7 0.7 (-0.3, 1.7)
cIAI 42/1382 3.0 31/1393 2.2 0.8 (-0.4, 2.0)
CAP 12/424 2.8 11/422 2.6 0.2 (-2.0, 2.4)
HAP 66/467 14.1 57/467 12.2 1.9 (-2.4, 6.3)
Non-VAPa 41/336 12.2 42/345 12.2 0.0 (-4.9, 4.9)
VAPa 25/131 19.1 15/122 12.3 6.8 (-2.1, 15.7)
RP 11/128 8.6 2/43 4.7 3.9 (-4.0, 11.9)
DFI 7/553 1.3 3/508 0.6 0.7 (-0.5, 1.8)
Overall Adjusted 150/3788 4.0 110/3646 3.0 0.6 (0.1, 1.2)**
The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.
Prothrombin time or other suitable anticoagulation test should be monitore |
