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<table> <tr> <td colspan="2"> Participant ID: <mark class='field' id='c9263103-b161-4bff-bc60-96b561c28f58'>BE-EORTC-40054-1074-3</mark> <br> Investigational product: <mark class='field' id='8801faeb-4b3f-4200-be7a-4cf8fadf389b'>Xeloda [Capecitabine]</mark> <br> Treatment group: <mark class='field' id='3d08d67d-726b-4cea-befb-cb868d9f1811'>Not specified in the provided context</mark> <br> </td> </tr> <tr> <td>AE (reason for narrative)</td> <td> <mark class='field' id='505ac46a-ff79-40f6-a9d0-7df917dd48e6'>SUDDEN DEATH (seriousness criteria of death, unexpectedness of event, relationship to study treatment)</mark> </td> </tr> <tr> <td>Age/sex/race/ethnicity/country</td> <td> <mark class='field' id='ac3202b6-e2fd-4a6d-a486-db4fb3024e07'>Age/sex/race/ethnicity/country: 56 years/female/Not reported/Not reported/BELGIUM</mark> </td> </tr> <tr> <td> <mark class='field' id='7b414783-3776-41d9-afb1-306a4ce5e817'>Rectal cancer</mark> diagnosis date (study day)</td> <td> <mark class='field' id='824ef869-2690-47f7-a7c2-8e57298f4f77'>Not specified in the provided context</mark> </td> </tr> <tr> <td>Relevant medical history (dates)</td> <td> <mark class='field' id='3d73b861-f320-487d-b522-61f07443e07f'>Rectal cancer (2011-2012) Heart failure (2012-2012) Depression (Not specified) Edema (2012-2012)</mark> </td> </tr> <tr> <td>Relevant concomitant medications (start year)</td> <td> <mark class='field' id='f24ba029-6ccd-434f-bd8f-ca4b9f856314'>Asaflow (Unknown) Simvastatine (Unknown) Metformin (Unknown) Pantomed (Unknown) Preterax (Unknown) Lysanxia (Unknown) Nortrilen (Unknown) Solian (Unknown) Sipralexa (Unknown) Torrem (2012)</mark> </td> </tr> <tr> <td>Relevant concomitant procedures (date)</td> <td> <mark class='field' id='fbeecc9a-fdc5-4bc6-ad49-4bb6d7c2593d'>Relevant concomitant procedures (date): Not specified in the provided context</mark> </td> </tr> <tr> <td>Date of randomization (study day)</td> <td> <mark class='field' id='5bbbdd4b-ce8f-4f91-96e5-391c1c1980b4'>Not specified in the provided context</mark> </td> </tr> <tr> <td>Date investigational product first administered (study day)</td> <td> <mark class='field' id='89b2de81-fa15-4361-8ac5-3c9be50855c7'>24 Aug 2011 (Day 1)</mark> </td> </tr> <tr> <td>Date investigational product last administered (study day)</td> <td> <mark class='field' id='81a2e930-643d-400c-80ff-26f34311f541'>27 Jan 2012 (Day 157)</mark> </td> </tr> <tr> <td>Participant status, date (study day), if applicable</td> <td> <mark class='field' id='69a3083c-8551-4e0d-9312-a75b40e03539'>Deceased, 27 Jan 2012 (Day 157)</mark> </td> </tr> </table> | |
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Participant <mark class='field'>BE-EORTC-40054-1074-3</mark> was a/an 56 years old <mark class="field">female</mark> participant who had an AE of <mark class="field">SUDDEN DEATH</mark> that was considered serious because <mark class="field">it led to death</mark> and it was notable because <mark class="field">the AE led to discontinuation from the study treatment and from the study due to the participant's death.</mark> | |
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