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<td height="30px"><span class="title"><a name="h1" id="h1"></a>The FIBROID Registry</span>
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<h3>Table 11. Summary of Adverse Events by Type</h3>
<table border="1" cellspacing="0" cellpadding="1" width="80%">
<thead>
<tr valign="bottom">
<th scope="col" width="40%">
<p>Adverse events by type</p></th>
<th scope="col" width="20%">
<p>N</p></th>
<th scope="col" width="20%">
<p>%</p></th>
</tr>
</thead>
<tr valign="top">
<td scope="row" width="40%">
<p>None</p></td>
<td width="20%" align="center">
<p>2,952</p></td>
<td width="20%" align="center">
<p>97%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Any event</p></td>
<td width="20%" align="center">
<p>89</p></td>
<td width="20%" align="center">
<p>3%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>1 event</p></td>
<td width="20%" align="center">
<p>84</p></td>
<td width="20%" align="center">
<p>2.8%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>2 events</p></td>
<td width="20%" align="center">
<p>5</p></td>
<td width="20%" align="center">
<p>0.2%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p><strong>Major events (class C, D and E)</strong></p></td>
<td width="20%" align="center">
<p><strong>20 (in 18 patients)</strong></p></td>
<td width="20%" align="center">
<p><strong>0.6%</strong></p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Nausea</p></td>
<td width="20%" align="center">
<p>4</p></td>
<td width="20%" align="center">
<p>0.1%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Drug reaction</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Prolonged pain<a href="#note1"><sup>a</sup></a></p></td>
<td width="20%" align="center">
<p>6</p></td>
<td width="20%" align="center">
<p>0.2%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Vessel injury</p></td>
<td width="20%" align="center">
<p>3</p></td>
<td width="20%" align="center">
<p>0.1%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Other complications</p></td>
<td width="20%" align="center">
<p>4</p></td>
<td width="20%" align="center">
<p>0.1%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Urinary retention</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Contrast reaction</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p><strong>Minor events (class A and B)</strong></p></td>
<td width="20%" align="center">
<p><strong>74 (in 71 patients)</strong></p></td>
<td width="20%" align="center">
<p><strong>2.3%</strong></p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Contrast reaction</p></td>
<td width="20%" align="center">
<p>3</p></td>
<td width="20%" align="center">
<p>0.1%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Drug reaction</p></td>
<td width="20%" align="center">
<p>5</p></td>
<td width="20%" align="center">
<p>0.2%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Device-related</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Groin hematoma</p></td>
<td width="20%" align="center">
<p>22</p></td>
<td width="20%" align="center">
<p>0.7%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Nausea</p></td>
<td width="20%" align="center">
<p>0</p></td>
<td width="20%" align="center">
<p>-</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Non-target embolization</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Prolonged pain</p></td>
<td width="20%" align="center">
<p>0</p></td>
<td width="20%" align="center">
<p>-</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Urinary retention</p></td>
<td width="20%" align="center">
<p>11</p></td>
<td width="20%" align="center">
<p>0.4%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Vessel injury</p></td>
<td width="20%" align="center">
<p>13</p></td>
<td width="20%" align="center">
<p>0.4%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Other</p></td>
<td width="20%" align="center">
<p>18</p></td>
<td width="20%" align="center">
<p>0.6%</p></td>
</tr>
<tr valign="top">
<td scope="row" colspan="2" width="40%">
<p><strong>Post-discharge adverse events (N = 2,729)</strong></p></td>
<td width="20%" align="center">
<p></p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>None</p></td>
<td width="20%" align="center">
<p>2,019</p></td>
<td width="20%" align="center">
<p>74%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Any event</p></td>
<td width="20%" align="center">
<p>710</p></td>
<td width="20%" align="center">
<p>26%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>1 event</p></td>
<td width="20%" align="center">
<p>519</p></td>
<td width="20%" align="center">
<p>19%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>2 events</p></td>
<td width="20%" align="center">
<p>128</p></td>
<td width="20%" align="center">
<p>4.6%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>3 events</p></td>
<td width="20%" align="center">
<p>49</p></td>
<td width="20%" align="center">
<p>1.8%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>4 or more events</p></td>
<td width="20%" align="center">
<p>14</p></td>
<td width="20%" align="center">
<p>0.5%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p><strong>Major events (Class C, D and E)</strong></p></td>
<td width="20%" align="center">
<p><strong>135 (in 111 pts)</strong></p></td>
<td width="20%" align="center">
<p><strong>4.1%</strong></p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Persistent bleeding</p></td>
<td width="20%" align="center">
<p>7</p></td>
<td width="20%" align="center">
<p>0.2%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Infection/possible infection</p></td>
<td width="20%" align="center">
<p>17</p></td>
<td width="20%" align="center">
<p>0.6%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>New hot flashes</p></td>
<td width="20%" align="center">
<p>2</p></td>
<td width="20%" align="center">
<p>0.07%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Thromboembolism</p></td>
<td width="20%" align="center">
<p>4</p></td>
<td width="20%" align="center">
<p>0.15%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Recurrent pain</p></td>
<td width="20%" align="center">
<p>65</p></td>
<td width="20%" align="center">
<p>2.4%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Sloughing/passing fibroid</p></td>
<td width="20%" align="center">
<p>19</p></td>
<td width="20%" align="center">
<p>0.7%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Spinal headache</p></td>
<td width="20%" align="center">
<p>1</p></td>
<td width="20%" align="center">
<p>0.03%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Other adverse event</p></td>
<td width="20%" align="center">
<p>20</p></td>
<td width="20%" align="center">
<p>0.7%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p><strong>Minor events (Class A and B)</strong></p></td>
<td width="20%" align="center">
<p><strong>848 (in 610)</strong></p></td>
<td width="20%" align="center">
<p><strong>22%</strong></p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Bleeding</p></td>
<td width="20%" align="center">
<p>55</p></td>
<td width="20%" align="center">
<p>1.8%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Headache</p></td>
<td width="20%" align="center">
<p>18</p></td>
<td width="20%" align="center">
<p>0.6%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>New hot flashes</p></td>
<td width="20%" align="center">
<p>156</p></td>
<td width="20%" align="center">
<p>5.7%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Infection/possible infection</p></td>
<td width="20%" align="center">
<p>82</p></td>
<td width="20%" align="center">
<p>3%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Pain</p></td>
<td width="20%" align="center">
<p>264</p></td>
<td width="20%" align="center">
<p>9.8%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Sloughing</p></td>
<td width="20%" align="center">
<p>123</p></td>
<td width="20%" align="center">
<p>4.5%</p></td>
</tr>
<tr valign="top">
<td scope="row" width="40%">
<p>Other event</p></td>
<td width="20%" align="center">
<p>150</p></td>
<td width="20%" align="center">
<p>5.4%</p></td>
</tr>
</table>
<p class="size2"><a id="note1" name="note1"></a><sup>a</sup> Requiring additional hospitalization.</p>
<p class="size2"><a href="fibreg2.htm#Adverse">Return to Document</a></p>
<p>&nbsp;</p>
<div class="footnote">
<p> The information on this page is archived and provided for reference purposes only.</p></div>
<p>&nbsp;</p>
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