Complex Event Analysis - Report

Complex Event Analysis - REPORT

Supporting narratives:

• challenge (Read more)
• Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
  About the SIMPLE Trials
  Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
  The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19
• High Level Abstractions:
• (covid-19,simple_trials)
• (covid-19,remdesivir)
• (covid-19,open-label)
• (open-label,remdesivir)
• (covid-19,multi-center)
• (covid-19,enzyme)
• (remdesivir,safety)
• (covid-19,infection)
• (remdesivir,simple_trials)
• (covid-19,safety)
• (covid-19,elevations)
• (multi-center,remdesivir)
• (countries,remdesivir)

• challenge (Read more)
• Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19.
• High Level Abstractions:
• (covid-19,remdesivir)

• challenge (Read more)
• Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
  For more information on Gilead's response to the coronavirus outbreak please visit the company's dedicated page: https://www.gilead..com/purpose/advancing-global-health/covid-19.
  Forward-Looking Statement
  This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19
• High Level Abstractions:
• (investigational,remdesivir)
• (remdesivir,risks)

• challenge (Read more)
• Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.
  Impact of Earlier Treatment
  In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms
• High Level Abstractions:
• (hospital,remdesivir)

• challenge (Read more)
• Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
  "These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course," said Aruna Subramanian, MD, Clinical Professor of Stanford University School of Medicine, and one of the lead investigators of the study
• High Level Abstractions:
• (hospital,remdesivir)

• challenge (Read more)
• Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
  "These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course," said Aruna Subramanian, MD, Clinical Professor of Stanford University School of Medicine, and one of the lead investigators of the study.
• High Level Abstractions:
• (remdesivir,stanford_university_school)

• challenge (Read more)
• Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
  About the SIMPLE Trials
  Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
  The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19.
• High Level Abstractions:
• (covid-19,manifestations)
• (manifestations,remdesivir)

• challenge (Read more)
• Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19
• High Level Abstractions:
• (covid-19,investigational)

• WIP (Read more)
• This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care."
  Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.
• High Level Abstractions:
• (covid-19,remdesivir)

• WIP (Read more)
• The results from the first 600 patients of this study are expected at the end of May.
  About Remdesivir
  Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
  About Gilead Sciences
  Gilead Sciences, Inc is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need
• High Level Abstractions:
• (remdesivir,safety)
• (covid-19,remdesivir)
• (remdesivir,virus)

• WIP (Read more)
• Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --
  FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2020-- Gilead Sciences, Inc (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 - 1.12] on Day 14)
• High Level Abstractions:
• (covid-19,manifestations)

• WIP (Read more)
• The study is being conducted at 180 trial sites around the world, including sites in the Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
  A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
  About Remdesivir
  Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19
• High Level Abstractions:
• (covid-19,intravenously)
• (covid-19,manifestations)

Target rule match count: 22.0 Challenge: 0.37 Momentum: 0.00 WIP: 0.13