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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002994-39 | EudraCT Number |
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| Name | Class |
|---|---|
| European Commission | OTHER |
| Centre Hospital Regional Universitaire de Limoges | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
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The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).
The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).
The key objectives of this study are to:
Primary objective:
Investigate the safety profile of two allogeneic Cx611 80 mL infusions administered through a central line within 3 days (on days 1 and 3) at a dose of 160 million cells each (320 million cells total) and to monitor any adverse event and potential immunological host responses against the administered cells during 90 days of follow-up after the first infusion.
Secondary objective:
Explore the clinical efficacy of Cx611 in terms of a reduction of the duration of mechanical ventilation and/or need for vasopressors and/or improved survival, and/or clinical cure of the sCABP, and other efficacy-related endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cx611 | Experimental | Subjects treated in an intensive care unit for sCABP, but that may be screened at the emergency department, will receive SoC therapy according to local guidelines plus two intravenous central line infusions of Cx611 at a fixed dose of 160 million expanded allogeneic adipose-derived stem cells (eASCs) each. |
|
| Placebo | Placebo Comparator | Subjects treated in an intensive care unit for sCABP, but that may be screened at the emergency department, will receive SoC therapy according to local guidelines plus two intravenous central line infusions of Ringer Lactate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cx611 | Biological | Two intravenous infusions, one on day 1 and another one on day 3. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to Day 90 | |
| Number of Participants With Adverse Events of Special Interest (AESI) | AESIs are predefined adverse events (AEs) that required close monitoring and prompt reporting to the sponsor. Protocol-specific AEs considered as AESI for this study are thromboembolic events and hypersensitivity reactions such as anaphylaxis. | Baseline up to Day 90 |
| Number of Participants With Hypersensitivity Reactions | Hypersensitivity reactions included anaphylaxis (changes in systolic and diastolic blood pressure, core temperature, respiratory rate [non-ventilated participants], heart rate), episodes of skin reactions and signs and symptoms of respiratory distress, which require therapeutic intervention including drugs and/or changes in mechanical ventilation setting. Number of participants with hypersensitivity reactions were reported for this outcome measure. | Baseline up to Day 90 |
| Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters on Day 1 | Day 1 | |
| Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters on Day 3 | Day 3 | |
| Number of Participants With Markedly Abnormal Laboratory Values | Baseline up to Day 90 | |
| Number of Participants With Anti-human Leukocyte Antigen Complex (Anti-HLA)/Donor Antibodies At Day 1, 14, and 90 | At Days 1, 14, and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation and Vasopressors Treatment-free Days | Participants with sCABP suffer either a respiratory failure that requires invasive mechanical ventilation and/or a severe hypotension that requires vasopressors. Number of days when participants were alive and free from mechanical ventilation and vasopressors were reported. | Baseline up to Day 28 |
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Inclusion criteria
Adult subjects of either gender (aged ≥18 years and ≤80 years old.)
Body weight between 50 kg and 100 kg.
Clinical diagnosis of acute (developed within ≤21 past days) community acquired bacterial pneumonia based on the presence of two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrate/s.
Subjects with pneumonia of sufficient severity requiring ICU management and with at least one of the two following major criteria of severity present for less than 18 hours:
NOTE: Patients that are for 18 hours or more under high flow nasal cannula (HFNC) at ≥50 liters per minute and FiO2 ≥0.6 or under non-mechanical ventilation (NMV) are not eligible for the study
Female subject of no childbearing potential i.e. non-fertile, pre-menarche, permanently sterile (i.e. underwent hysterectomy, bilateral salpingectomy or bilateral ovariectomy) or post-menopausal (history of no menses for at least 12 months without an alternative medical cause) or Woman of childbearing potential* with a negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]) and agree to use an adequate method of contraception for three months after the last dose of the IMP according to her preferred and usual life style. Adequate methods of female contraception for this study are: sexual abstinence (refraining from heterosexual intercourse), hormonal contraception (both progesterone-only or combined oestrogen and progesterone; both with inhibition of ovulation or where inhibition of ovulation is not the primary mechanism of action), intra-uterine device, bilateral tubal occlusion, condom use by male sexual partner(s) or medically-assessed successfully vasectomized male sexual partner(s).
*A woman of childbearing potential is a woman between menarche and post-menopause (history of no menses for at least 12 months without an alternative medical cause) unless she has undergone hysterectomy, bilateral salpingectomy or bilateral ovariectomy Male subject agreeing to use one of the following methods of birth control according to his preferred and usual life style for three months after the last dose of the IMP: sexual abstinence (refraining from heterosexual intercourse), use of condoms or medically-assessed successful vasectomy , or having a female sexual partner(s) who is using an adequate method of contraception as described above.
Signed informed consent provided by the participant, the relatives or the designated legal representative according to local guidelines.
Exclusion criteria A patient will not be included in the study if he/she meets ANY of the following criteria:
Subjects with Hospital acquired (HAP)-, Health Care acquired (HCAP)- or Ventilator associated-pneumonia (VAP).
Subjects with pneumonia exclusively of viral or fungal origin*. Subjects with bacterial pneumonia co-infected with viruses and/or other microorganisms may be entered into the study.
*Due to the short time window (up to 18 hours) between fulfillment of severity criteria (i.e. initiation of invasive mechanical ventilation or vasopressors administration, whichever comes first) and the start of the first dose of study treatment, patients with a pneumonia of suspected bacterial origin by any established standard diagnostic method routinely applied at the study site (e.g. urinary antigen test, rt-PCR) can be entered into the study (confirmation of bacterial origin must be obtained afterwards).
Subjects with known or suspected Pneumocystis jirovecii (formerly known as Pneumocystis carinii) pneumonia.
Subjects with an aspiration pneumonia.
Subjects with known active tuberculosis.
Subjects with a history of post-obstructive pneumonia.
Subjects with cystic fibrosis.
Subjects with any chronic lung disease requiring oxygen therapy at home.
Presence of infection in another organ location caused by same pathogen (e.g. pneumococcal meningitis in the context of pneumococcal pneumonia).
Subjects expected to have rapidly fatal disease within 72 hours after randomisation.
Inability to maintain a mean arterial pressure ≥50 mmHg prior to screening despite the presence of vasopressors and intravenous fluids.
Subjects not expected to survive for 3 months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases.
Subjects with a history of malignancy in the 5 years prior to screening, except for successfully surgically treated non-melanoma skin malignancies.
Subjects with known primary immunodeficiency disorder or with HIV infection and acquired immune deficiency syndrome (AIDS) with CD4 count <200 cells/mm^3 or not receiving highly active antiretroviral therapy (HAART) for HIV.
Subjects receiving immunosuppressant therapy (including chronic treatment with anti-tumour necrosis factor alpha (TNFα ) or on chronic high doses of steroids (single administration of ≥2 mg/kg body weight or 20 mg/day of prednisone or equivalent for ≥2 weeks).
Chronic granulocytopenia, not thought to be due to sepsis, as evidenced by an absolute neutrophil count <500 per µL>21 days prior to onset of pneumonia symptoms.
Subjects who received stem cell therapy, or allogenic transplantation (organ or bone marrow transplant) within the past 6 months.
Subjects receiving treatment with a biological agent (e.g. antibodies, cells), immunotherapy or plasma exchange treatment within the last 8 weeks.
Subjects currently receiving, or having received another investigational medication within 90 days prior to start of the study (or 5 half-lives of the investigational compound, whichever is longer).
Known allergies or hypersensitivity to Penicillin or Streptomycin and/or any component of CryoStor® CS10.
Subjects with a known liver function impairment associated with liver cirrhosis (Child Pugh C) or known oesophageal varices.
Subjects hospitalised within the previous 15 days.
Conditions resulting in a New York Heart Association or Canadian Cardiovascular Society Class IV functional status.
End-stage neuromuscular disorders (e.g. motor neuron diseases, myasthenia gravis, etc.) or cerebral disorders that impair weaning.
Patients with quadriplegia (traumatic or otherwise).
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium | ||
| UZ Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37918129 | Derived | Laterre PF, Sanchez Garcia M, van der Poll T, Wittebole X, Martinez-Sagasti F, Hernandez G, Ferrer R, Caballero J, Cadogan KA, Sullivan A, Zhang B, de la Rosa O, Lombardo E, Francois B; SEPCELL Study Group. The safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial. J Crit Care. 2024 Feb;79:154446. doi: 10.1016/j.jcrc.2023.154446. Epub 2023 Oct 31. | |
| 33238991 |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Adult participants with severe community-acquired bacterial pneumonia (sCABP) and admitted to the intensive care unit (ICU) were enrolled in 1 of the 2 treatment groups to receive Cx611 or placebo on Days 1 and 3.
Participants took part in the study at 20 investigative sites in Belgium, France, Lithuania, and Spain from 30 Jan 2017 to 07 July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3. |
| FG001 | Cx611 160 mL | Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all randomized participants who received at least one dose of the study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3. |
| BG001 | Cx611 160 mL | Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 90 |
|
Treatment-emergent adverse events are adverse events that started from the signature of the informed consent (Baseline) up to Day 730
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received SoC therapy followed by two 80 mL central line infusions of placebo, intravenously, on Days 1 and 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolysis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2019 | Jul 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2020 | Jul 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
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| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| OTHER |
| Hospital San Carlos, Madrid | OTHER |
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| Placebo |
| Other |
Two intravenous infusions, one on day 1 and another one on day 3. |
|
| Percentage of Participants Alive and Free of Both Mechanical Ventilation and Vasopressors at Day 29 | Participants with sCABP suffer either a respiratory failure that requires invasive mechanical ventilation and/or a severe hypotension that requires vasopressors. Percentage of participants who were alive and free of both mechanical ventilation and vasopressors at Day 29 were reported. | Day 29 |
| Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Day 29 |
| Number of Ventilator Free Days (VeFD) | VeFD are defined as one point for each day during the measurement period that participants are both alive and free from mechanical ventilation. | Baseline up to Day 28 |
| Percentage of Participants Alive and Free of Vasopressors at Day 29 | Day 29 |
| Number of Vasopressor Treatment-free Days (VaFD) | VaFD over 28 days defined as one point for each day during the measurement period that participants are both alive and free of vasopressors. | Baseline up to Day 28 |
| Time to End of Invasive Mechanical Ventilation | Time in days, from the start date of invasive mechanical ventilation to the first stop date of invasive mechanical ventilation (that is, first time the participant ends mechanical ventilation), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 29 |
| Time to End of Invasive and/or Non-invasive Mechanical Ventilation | Time in days, from the start date of invasive or non-invasive mechanical ventilation to the first stop date of invasive or non-invasive mechanical ventilation (that is, first time the participant ends mechanical ventilation), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 29 |
| Time to End of Vasopressors Treatment | Time in days, from the start date of vasopressors treatment to the first stop date of vasopressors treatment (that is, first time the participant ends vasopressors treatment), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 29 |
| Number of Participants With sCABP Clinical Response Visit at Days 8-10, 14, and 29 | Cure:complete pneumonia resolution at baseline(BL),no new pneumonia symptoms/complications attributable.Non-response:failure related/unrelated to pneumonia:persistence/progression of BL signs/symptoms of pneumonia;BL radiographic abnormalities after atleast 2 days of treatment;development of new pulmonary/extra pulmonary findings consistent with active infection/development of new pulmonary infection/extrapulmonary infection requiring antimicrobial therapy;persistence/progression of BL signs/symptoms of severe sepsis;development of new signs/symptoms of severe sepsis;death due to sepsis.Non-response-failure unrelated to pneumonia:any cause of clinical response failure that in investigator's judgement is unrelated to index pneumonia(e.g.myocardial infarction, pulmonary thromboembolism, sepsis of urinary origin etc).Indeterminate:extenuating circumstances precluding classification to one of the above. | Days 8 to 10, 14, and 29 |
| Time to sCABP Clinical Cure | Cure is defined as complete resolution of pneumonia signs and symptoms present at baseline, no new symptoms or complications attributable to the pneumonia. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 29 |
| Duration of Antibiotic Treatment | Baseline up to Day 29 |
| Percentage of Participants With Pneumonia Recurrence or Reinfection After Clinical Cure | Pneumonia recurrence is defined as a new acute clinical episode of pneumonia, after clinical cure of the episode that qualified the participant for the study, based on the presence of two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrate/s or clinically significant worsening of previous ones. If a bacterial pathogen isolated in the recurrent episode is phenotypically different from the one isolated in the previous episode this will be considered as reinfection. | Days 14, 29, and 90 |
| Time to Recurrence or Reinfection of Pneumonia After Clinical Cure at sCABP Clinical Response Assessments | Pneumonia recurrence is defined as a new acute clinical episode of pneumonia, after clinical cure of the episode that qualified the participant for the study, based on the presence of two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrates or clinically significant worsening of previous ones. If a bacterial pathogen isolated in the recurrent episode is phenotypically different from the one isolated in the previous episode this will be considered as reinfection. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 90 |
| 28-day All-cause Mortality | Day 28 |
| 28-day sCABP-associated Mortality | Day 28 |
| Survival at Baseline, Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 | Survival data for percentage of participants at Baseline and at Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 was assessed and reported. | At Baseline, Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 |
| Time to Death | Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 90 |
| Time to Discharge From Intensive Care Unit (ICU) | Time to discharge from ICU was defined, in days, as the time between informed consent date and the date of discharge from the ICU. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 730 |
| Time to Discharge From Hospital | Time to discharge from hospital was defined, in days, as the time between informed consent date and the date of discharge from the hospital. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | Baseline up to Day 730 |
| Length of Stay (LOS) in ICU and Hospital After Randomization | Baseline up to Day 730 |
| Number of ICU-free Days | ICU-free days will be defined as the number of days during which the participant was not in ICU, starting from the randomization date, to Day 29, or day of discontinuation. | Baseline up to Day 29 |
| Change From Baseline in Sepsis-related Organ Failure Assessment (SOFA) Score During Stay at ICU | The total SOFA Score is a composite of six sub scores representing the degree of dysfunction of six organ systems: Respiratory, Cardiovascular, Liver, Renal, Coagulation and Central Nervous System. Each organ system sub score ranges from 0 to 4 points. The total SOFA Score is the sum of the six-organ system sub scores. Accordingly, the total SOFA Score may range from a minimum score of 0 to a maximum score of 24. Higher scores indicate greater degree of dysfunction. | Baseline up to Day 29 |
| Number of Participants Categorized Based on the Chest X-ray Assessments Compared to Previous Chest X-ray Assessment | Number of participants with chest X-ray assessment compared to the previous assessment were assessed and reported. Number of participants which showed improvement, remission, stabilization, and worsening compared to previous CXR were reported. Cumulative data is reported only for participants who were assessed from Day 8-10. | Days 1, 2, 3, 4, 5, 6, 7, 8-10, 14, and 29 |
| Change in the Ratio of the Partial Pressure of Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio) | Baseline up to Day 7 |
| Number of Participants Requiring Mechanical Ventilation or Non-invasive Ventilation Twelve Hours After the Second Investigational Medicinal Product (IMP) Infusion | Day 3: 0 to 12 hours post-IMP infusion |
| Number Participants Using Rescue Antibiotics | Any new intravenous antibiotic for CABP indication that was started after Day 1 and before Day 29 was considered a rescue antibiotic. | Baseline up to Day 29 |
| Brussels |
| 1090 |
| Belgium |
| CHU Sart Tilman | Liège | 4000 | Belgium |
| Clinique Saint-Pierre | Ottignies | 1340 | Belgium |
| Centre Hospitalier d'Angoulême | Angoulême | 16959 | France |
| Centre Hospitalier Victor Dupouy | Argenteuil | 95107 | France |
| Centre Hospitalier Universitaire de Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| CHU Bocage | Dijon | 21000 | France |
| Centre Hospitalier Departemental les Ouidairies | La Roche-sur-Yon | 85925 | France |
| Centre Hospitalier Départemental les Oudairies | La Roche-sur-Yon | 85925 | France |
| Centre Hospitalier Regional Universitaire de Lille | Lille | 59037 | France |
| Centre Hospitalier Universitaire de Limoges - CHU Dupuytren | Limoges | 87000 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| Centre Hospitalier Regional d'Orleans | Orléans | 45067 | France |
| CHRU de Strasbourg | Strasbourg | 21000 | France |
| CHU TOURS - Hôpital Bretonneau | Tours | 37000 | France |
| Azienda Ospedaliera San'Andrea. UOC Anestesia e Terapia Intensiva | Roma | 00189 | Italy |
| Klaipėda Republican Hospital, The Pulmonology and Allergology Department | Klaipėda | 92231 | Lithuania |
| St. Olavs Hospital, Department of Intensive care Clinical Immunology and Infectious Disease | Trondheim | 7030 | Norway |
| Hospital Universitari Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Mútua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic I Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | 25198 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitari de Tarragona Joan XXIII | Tarragona | 43005 | Spain |
| Hospital Virgen de la Salud | Toledo | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Derived |
| Laterre PF, Sanchez-Garcia M, van der Poll T, de la Rosa O, Cadogan KA, Lombardo E, Francois B. A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. BMC Pulm Med. 2020 Nov 25;20(1):309. doi: 10.1186/s12890-020-01324-2. |
| Lost to Follow-up |
|
| Participant doesn't want to come back to the hospital for the visit |
|
| Visit 11 not done by mistake |
|
| Enrolled, not treated |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Adverse Events of Special Interest (AESI) | AESIs are predefined adverse events (AEs) that required close monitoring and prompt reporting to the sponsor. Protocol-specific AEs considered as AESI for this study are thromboembolic events and hypersensitivity reactions such as anaphylaxis. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 90 |
|
|
|
| Primary | Number of Participants With Hypersensitivity Reactions | Hypersensitivity reactions included anaphylaxis (changes in systolic and diastolic blood pressure, core temperature, respiratory rate [non-ventilated participants], heart rate), episodes of skin reactions and signs and symptoms of respiratory distress, which require therapeutic intervention including drugs and/or changes in mechanical ventilation setting. Number of participants with hypersensitivity reactions were reported for this outcome measure. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 90 |
|
|
|
| Primary | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters on Day 1 | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters on Day 3 | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Primary | Number of Participants With Markedly Abnormal Laboratory Values | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 90 |
|
|
|
| Primary | Number of Participants With Anti-human Leukocyte Antigen Complex (Anti-HLA)/Donor Antibodies At Day 1, 14, and 90 | The safety population included all randomized participants who received at least one dose of the study treatment. Here "number analyzed" are the participants who were evaluable for this outcome measure at given time points. | Posted | Count of Participants | Participants | At Days 1, 14, and 90 |
|
|
|
| Secondary | Mechanical Ventilation and Vasopressors Treatment-free Days | Participants with sCABP suffer either a respiratory failure that requires invasive mechanical ventilation and/or a severe hypotension that requires vasopressors. Number of days when participants were alive and free from mechanical ventilation and vasopressors were reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | Full Range | days | Baseline up to Day 28 |
|
|
|
| Secondary | Percentage of Participants Alive and Free of Both Mechanical Ventilation and Vasopressors at Day 29 | Participants with sCABP suffer either a respiratory failure that requires invasive mechanical ventilation and/or a severe hypotension that requires vasopressors. Percentage of participants who were alive and free of both mechanical ventilation and vasopressors at Day 29 were reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Number | percentage of participants | Day 29 |
|
|
|
| Secondary | Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Number | percentage of participants | Day 29 |
|
|
|
| Secondary | Number of Ventilator Free Days (VeFD) | VeFD are defined as one point for each day during the measurement period that participants are both alive and free from mechanical ventilation. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | Full Range | days | Baseline up to Day 28 |
|
|
|
| Secondary | Percentage of Participants Alive and Free of Vasopressors at Day 29 | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Number | percentage of participants | Day 29 |
|
|
|
| Secondary | Number of Vasopressor Treatment-free Days (VaFD) | VaFD over 28 days defined as one point for each day during the measurement period that participants are both alive and free of vasopressors. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | Full Range | days | Baseline up to Day 28 |
|
|
|
| Secondary | Time to End of Invasive Mechanical Ventilation | Time in days, from the start date of invasive mechanical ventilation to the first stop date of invasive mechanical ventilation (that is, first time the participant ends mechanical ventilation), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 29 |
|
|
|
| Secondary | Time to End of Invasive and/or Non-invasive Mechanical Ventilation | Time in days, from the start date of invasive or non-invasive mechanical ventilation to the first stop date of invasive or non-invasive mechanical ventilation (that is, first time the participant ends mechanical ventilation), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 29 |
|
|
|
| Secondary | Time to End of Vasopressors Treatment | Time in days, from the start date of vasopressors treatment to the first stop date of vasopressors treatment (that is, first time the participant ends vasopressors treatment), or death. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 29 |
|
|
|
| Secondary | Number of Participants With sCABP Clinical Response Visit at Days 8-10, 14, and 29 | Cure:complete pneumonia resolution at baseline(BL),no new pneumonia symptoms/complications attributable.Non-response:failure related/unrelated to pneumonia:persistence/progression of BL signs/symptoms of pneumonia;BL radiographic abnormalities after atleast 2 days of treatment;development of new pulmonary/extra pulmonary findings consistent with active infection/development of new pulmonary infection/extrapulmonary infection requiring antimicrobial therapy;persistence/progression of BL signs/symptoms of severe sepsis;development of new signs/symptoms of severe sepsis;death due to sepsis.Non-response-failure unrelated to pneumonia:any cause of clinical response failure that in investigator's judgement is unrelated to index pneumonia(e.g.myocardial infarction, pulmonary thromboembolism, sepsis of urinary origin etc).Indeterminate:extenuating circumstances precluding classification to one of the above. | The safety population included all randomized participants who received at least one dose of the study treatment. Here "number analyzed" are the participants who were evaluable for this outcome measure at given time points. | Posted | Count of Participants | Participants | Days 8 to 10, 14, and 29 |
|
|
|
| Secondary | Time to sCABP Clinical Cure | Cure is defined as complete resolution of pneumonia signs and symptoms present at baseline, no new symptoms or complications attributable to the pneumonia. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 29 |
|
|
|
| Secondary | Duration of Antibiotic Treatment | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | Full Range | days | Baseline up to Day 29 |
|
|
|
| Secondary | Percentage of Participants With Pneumonia Recurrence or Reinfection After Clinical Cure | Pneumonia recurrence is defined as a new acute clinical episode of pneumonia, after clinical cure of the episode that qualified the participant for the study, based on the presence of two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrate/s or clinically significant worsening of previous ones. If a bacterial pathogen isolated in the recurrent episode is phenotypically different from the one isolated in the previous episode this will be considered as reinfection. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. Here, "number analyzed" are the participants who were evaluable for the outcome measure at given time points. | Posted | Number | percentage of participants | Days 14, 29, and 90 |
|
|
|
| Secondary | Time to Recurrence or Reinfection of Pneumonia After Clinical Cure at sCABP Clinical Response Assessments | Pneumonia recurrence is defined as a new acute clinical episode of pneumonia, after clinical cure of the episode that qualified the participant for the study, based on the presence of two relevant signs (fever, tachypnoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrates or clinically significant worsening of previous ones. If a bacterial pathogen isolated in the recurrent episode is phenotypically different from the one isolated in the previous episode this will be considered as reinfection. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 90 |
|
|
|
| Secondary | 28-day All-cause Mortality | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | 28-day sCABP-associated Mortality | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | Survival at Baseline, Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 | Survival data for percentage of participants at Baseline and at Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 was assessed and reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Baseline, Days 10, 20, 30, 40, 50, 60, 70, 80, and 90 |
|
|
|
| Secondary | Time to Death | Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 90 |
|
|
|
| Secondary | Time to Discharge From Intensive Care Unit (ICU) | Time to discharge from ICU was defined, in days, as the time between informed consent date and the date of discharge from the ICU. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 730 |
|
|
|
| Secondary | Time to Discharge From Hospital | Time to discharge from hospital was defined, in days, as the time between informed consent date and the date of discharge from the hospital. Median survival time and the associated 95% confidence interval based on Kaplan-Meier estimation are reported. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 730 |
|
|
|
| Secondary | Length of Stay (LOS) in ICU and Hospital After Randomization | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | Full Range | days | Baseline up to Day 730 |
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|
|
| Secondary | Number of ICU-free Days | ICU-free days will be defined as the number of days during which the participant was not in ICU, starting from the randomization date, to Day 29, or day of discontinuation. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Median | Full Range | days | Baseline up to Day 29 |
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|
|
| Secondary | Change From Baseline in Sepsis-related Organ Failure Assessment (SOFA) Score During Stay at ICU | The total SOFA Score is a composite of six sub scores representing the degree of dysfunction of six organ systems: Respiratory, Cardiovascular, Liver, Renal, Coagulation and Central Nervous System. Each organ system sub score ranges from 0 to 4 points. The total SOFA Score is the sum of the six-organ system sub scores. Accordingly, the total SOFA Score may range from a minimum score of 0 to a maximum score of 24. Higher scores indicate greater degree of dysfunction. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. Here, "number analyzed" are the participants who were evaluable for the outcome measure at given time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline up to Day 29 |
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|
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| Secondary | Number of Participants Categorized Based on the Chest X-ray Assessments Compared to Previous Chest X-ray Assessment | Number of participants with chest X-ray assessment compared to the previous assessment were assessed and reported. Number of participants which showed improvement, remission, stabilization, and worsening compared to previous CXR were reported. Cumulative data is reported only for participants who were assessed from Day 8-10. | The safety population included all randomized participants who received at least one dose of the study treatment. Here, "overall number of participants analyzed" are those who were evaluable for this outcome measure. Here, "number analyzed" are the participants who were evaluable for the outcome measure at given time points. | Posted | Count of Participants | Participants | Days 1, 2, 3, 4, 5, 6, 7, 8-10, 14, and 29 |
|
|
|
| Secondary | Change in the Ratio of the Partial Pressure of Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio) | The safety population included all randomized participants who received at least one dose of the study treatment. Here "number analyzed" n are the participants who were evaluable for this outcome measure at given categories. | Posted | Mean | Standard Deviation | P/F ratio | Baseline up to Day 7 |
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|
|
| Secondary | Number of Participants Requiring Mechanical Ventilation or Non-invasive Ventilation Twelve Hours After the Second Investigational Medicinal Product (IMP) Infusion | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Day 3: 0 to 12 hours post-IMP infusion |
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|
|
| Secondary | Number Participants Using Rescue Antibiotics | Any new intravenous antibiotic for CABP indication that was started after Day 1 and before Day 29 was considered a rescue antibiotic. | The safety population included all randomized participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
|
|
|
| 12 |
| 41 |
| 20 |
| 41 |
| 41 |
| 41 |
| EG001 | Cx611 160 mL | Participants received SoC therapy followed by two 80 mL central line infusions of Cx611, intravenously, on Days 1 and 3 at a fixed dose of 160 million eASCs (320 million cells total). | 13 | 42 | 24 | 42 | 42 | 42 |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Atrioventricular dissociation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fibrosis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Prostate infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Toxic shock syndrome | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspiration bronchial | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Mitral valve replacement | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thymus disorder | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Primary hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Device related thrombosis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Puncture site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Citrobacter infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Serratia infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Axillary nerve injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Eschar | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Cell death | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Agitation | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Akinesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Essential tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Penile oedema | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin maceration | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Participants with Anti-HLA/Donor Antibodies at Day 14 |
|
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| Participants with Anti-HLA/Donor Antibodies at Day 90 |
|
|
| Days 8 to 10 (Failure not resulting in death) |
|
|
| Days 8 to 10 (Indeterminate) |
|
|
| Days 8 to 10 (Missing) |
|
|
| Day 14 (Cure) |
|
|
| Day 14 (Failure not resulting in death) |
|
|
| Day 14 (Indeterminate) |
|
|
| Day 14 (Missing) |
|
|
| Day 29 (Cure) |
|
|
| Day 29 (Failure not resulting in death) |
|
|
| Day 29 (Indeterminate) |
|
|
| Day 29 (Missing) |
|
|
| Day 14: Reinfection |
|
|
| Day 29: Recurrence |
|
|
| Day 29: Reinfection |
|
|
| Day 90: Recurrence |
|
|
| Day 90: Reinfection |
|
|
| Day 20 |
|
| Day 30 |
|
| Day 40 |
|
| Day 50 |
|
| Day 60 |
|
| Day 70 |
|
| Day 80 |
|
| Day 90 |
|
| Change at Day 29 |
|
|
| Remission at Day 1: Compared to previous chest X-ray |
|
|
| Stabilization at Day 1: Compared to previous chest X-ray |
|
|
| Worsening at Day 1: Compared to previous chest X-ray |
|
|
| Improvement at Day 2: Compared to previous chest X-ray |
|
|
| Remission at Day 2: Compared to previous chest X-ray |
|
|
| Stabilization at Day 2: Compared to previous chest X-ray |
|
|
| Worsening at Day 2: Compared to previous chest X-ray |
|
|
| Improvement at Day 3: Compared to previous chest X-ray |
|
|
| Remission at Day 3: Compared to previous chest X-ray |
|
|
| Stabilization at Day 3: Compared to previous chest X-ray |
|
|
| Worsening at Day 3: Compared to previous chest X-ray |
|
|
| Improvement at Day 4: Compared to previous chest X-ray |
|
|
| Remission at Day 4: Compared to previous chest X-ray |
|
|
| Stabilization at Day 4: Compared to previous chest X-ray |
|
|
| Worsening at Day 4: Compared to previous chest X-ray |
|
|
| Improvement at Day 5: Compared to previous chest X-ray |
|
|
| Remission at Day 5: Compared to previous chest X-ray |
|
|
| Stabilization at Day 5: Compared to previous chest X-ray |
|
|
| Worsening at Day 5: Compared to previous chest X-ray |
|
|
| Improvement at Day 6: Compared to previous chest X-ray |
|
|
| Remission at Day 6: Compared to previous chest X-ray |
|
|
| Stabilization at Day 6: Compared to previous chest X-ray |
|
|
| Worsening at Day 6: Compared to previous chest X-ray |
|
|
| Improvement at Day 7: Compared to previous chest X-ray |
|
|
| Remission at Day 7: Compared to previous chest X-ray |
|
|
| Stabilization at Day 7: Compared to previous chest X-ray |
|
|
| Worsening at Day 7: Compared to previous chest X-ray |
|
|
| Improvement at Days 8-10: Compared to previous chest X-ray |
|
|
| Remission at Days 8-10: Compared to previous chest X-ray |
|
|
| Stabilization at Days 8-10: Compared to previous chest X-ray |
|
|
| Worsening at Days 8-10: Compared to previous chest X-ray |
|
|
| Improvement at Day 14: Compared to previous chest X-ray |
|
|
| Remission at Day 14: Compared to previous chest X-ray |
|
|
| Stabilization at Day 14: Compared to previous chest X-ray |
|
|
| Worsening at Day 14: Compared to previous chest X-ray |
|
|
| Improvement at Day 29: Compared to previous chest X-ray |
|
|
| Remission at Day 29: Compared to previous chest X-ray |
|
|
| Stabilization at Day 29: Compared to previous chest X-ray |
|
|
| Worsening at Day 29: Compared to previous chest X-ray |
|
|
| Change at Day 7 |
|
|