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| ID | Type | Description | Link |
|---|---|---|---|
| F1K-MC-EVDP | Other Identifier | Eli Lilly and Company |
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The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drotrecogin alfa (activated) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drotrecogin alfa (activated) | Drug | 24 microgram/kilogram/hour, intravenous, 96 hours (hr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day All-Cause Mortality | Expressed as percentage of participants who died from any cause at Day 28 endpoint. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency | Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%). | Day 28 |
| Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28 | Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | Alabama | 35294 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25928214 | Derived | Povoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19(1):193. doi: 10.1186/s13054-015-0921-x. | |
| 22616830 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drotrecogin Alfa (Activated) | 24 microgram/kilogram/hour, intravenous, 96 hours |
| FG001 | Placebo | 0.9% sodium chloride, intravenous, 96 hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline to Day 28 |
|
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| Placebo | Drug | 0.9% sodium chloride, intravenous, 96 hours |
|
Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. |
| Day 1 through Day 28 |
| Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | Day 1 through Day 28 |
| Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | Day 1 through Day 28 |
| 90-Day Mortality | Expressed as percentage of participants who died from any cause at Day 90 endpoint. | Day 90 |
| 180-Day Mortality | Expressed as percentage of participants who died from any cause at Day 180 endpoint. | Day 180 |
| Median Survival Time | Day 180 |
| EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180 | EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state. | Baseline and Days 28 and 90 and 180 |
| EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180 | The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life). | Baseline and Days 28 and 90 and 180 |
| Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180 | SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing. | Baseline and Days 28 and 90 and 180 |
| Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint | Baseline through Day 28 |
| Baseline through Day 28 |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Loma Linda | California | 92350 | United States |
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| Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22. |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Day 29 to Day 90 |
|
|
| Day 91 to Day 180 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Drotrecogin Alfa (Activated) | 24 microgram/kilogram/hour, intravenous, 96 hours |
| BG001 | Placebo | 0.9% sodium chloride, intravenous, 96 hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Primary Site of Infection | Number | participants |
| ||||||||||||||||
| Cardiovascular Sequential Organ Failure Assessment (SOFA) Score | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. There were 12 participants in drotrecogin alfa (activated) and 14 participants in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Respiratory Sequential Organ Failure Assessment (SOFA) Score | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. There were 35 participants in drotrecogin alfa (activated) and 34 participants in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Renal Sequential Organ Failure Assessment (SOFA) Score | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. There were 12 participants in drotrecogin alfa (activated) and 17 participants in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Coagulation Sequential Organ Failure Assessment (SOFA) Score | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating worsening coagulopathy (decreasing platelet counts). There were 11 participants in drotrecogin alfa (activated) and 17 participants in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Liver Sequential Organ Failure Assessment (SOFA) Score | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing liver dysfunction. There were 61 participants in drotrecogin alfa (activated) and 70 participants in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Acute Physiology and Chronic Health Evaluation II (APACHE II) score is a severity-of-disease classification system. Scores range from 0 to 71. Higher scores correspond to more severe disease and a higher risk of death. There were 4 participants in drotrecogin alfa (activated) and 1 participant in placebo who were unspecified and were not included in the calculation of mean and standard deviation. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 28-Day All-Cause Mortality | Expressed as percentage of participants who died from any cause at Day 28 endpoint. | All randomized participants with known mortality status at Day 28. | Posted | Number | percentage of participants | Day 28 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency | Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%). | All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28. | Posted | Number | percentage of participants | Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | Posted | Mean | Standard Deviation | units on a scale | Day 1 through Day 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | Posted | Mean | Standard Deviation | units on a scale | Day 1 through Day 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. | Posted | Mean | Standard Deviation | units on a scale | Day 1 through Day 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 90-Day Mortality | Expressed as percentage of participants who died from any cause at Day 90 endpoint. | All randomized participants with known mortality status at Day 90. | Posted | Number | percentage of participants | Day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 180-Day Mortality | Expressed as percentage of participants who died from any cause at Day 180 endpoint. | All randomized participants with known mortality status at Day 180. | Posted | Number | percentage of participants | Day 180 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Survival Time | All randomized participants excluding those with unknown mortality status at Day 180. | Posted | Median | Full Range | days | Day 180 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180 | EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state. | All randomized participants with EQ-5D VAS data at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Days 28 and 90 and 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180 | The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life). | All randomized participants with EQ-5D total score data at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Days 28 and 90 and 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180 | SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing. | All randomized participants with SF-12 score data at the specified time points. | Posted | Median | Standard Deviation | units on a scale | Baseline and Days 28 and 90 and 180 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28 | Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days. | Participants who received study drug. | Posted | Number | percentage of participants | Baseline through Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint | Participants who received study drug. | Posted | Number | percentage of participants | Baseline through Day 28 |
|
|
Day 0 to Day 28
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drotrecogin Alfa (Activated) | 24 microgram/kilogram/hour, intravenous, 96 hours | 119 | 833 | 151 | 833 | ||
| EG001 | Placebo | 0.9% sodium chloride, intravenous, 96 hours | 96 | 833 | 119 | 833 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Supraventricular tachyarrhythmia | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pupils unequal | Eye disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal ischaemia | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Peritoneal haematoma | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Sigmoiditis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Brain death | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Device dislocation | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Idiosyncratic drug reaction | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Colon gangrene | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Meningitis pneumococcal | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal stoma necrosis | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Suture rupture | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Pulse absent | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hypoglycaemic seizure | Metabolism and nutrition disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Mucoepidermoid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Dementia alzheimer's type | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Neuroleptic malignant syndrome | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Scleral haemorrhage | Eye disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Abdominal wall haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Bloody discharge | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MEDDRA_V14 | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MEDDRA_V14 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Prothrombin time shortened | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Troponin increased | Investigations | MEDDRA_V14 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA_V14 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Scrotal haematocoele | Reproductive system and breast disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Haematoma | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Intra-abdominal haematoma | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Intra-abdominal haemorrhage | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Jugular vein thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Necrosis ischaemic | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Subclavian vein thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Vena cava thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Venous thrombosis | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MEDDRA_V14 | Systematic Assessment |
|
The only disclosure restriction on the site PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. An independent Steering Committee responsible for data analyses and publications did not have an embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| C421124 | drotrecogin alfa activated |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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| Withdrawal by Subject |
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| Brazil |
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| Belgium |
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| Australia |
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| Netherlands |
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| Germany |
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| New Zealand |
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| Blood |
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| Bone |
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| Central Nervous System |
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| Head |
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| Lung |
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| Other |
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| Pleura |
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| Skin or Skin Structure |
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| Urinary Tract |
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| Unknown |
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