Microbiota Restoration Therapy for Recurrent Clostridium... | NCT03244644 | Trialant
NCT03244644
Sponsor
Rebiotix Inc.
Status
Completed
Last Update Posted
Jul 10, 2024Actual
Enrollment
320Actual
Phase
Phase 3
Conditions
Clostridium Difficile Infection (CDI)
Interventions
RBX2660
Placebo
Open label RBX2660 (only for confirmed CDI recurrence)
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT03244644
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2017-01
Secondary IDs
Not provided
Brief Title
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Official Title
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection
Acronym
Not provided
Organization
Rebiotix Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 31, 2017Actual
Primary Completion Date
Apr 2, 2020Actual
Completion Date
Aug 3, 2020Actual
First Submitted Date
Aug 2, 2017
First Submission Date that Met QC Criteria
Aug 8, 2017
First Posted Date
Aug 9, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2023
Results First Submitted that Met QC Criteria
Aug 10, 2023
Results First Posted Date
Aug 14, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 29, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Aug 14, 2023Actual
Last Update Submitted Date
Jul 8, 2024
Last Update Posted Date
Jul 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Rebiotix Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.
Detailed Description
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the study will be a Bayesian hierarchical model, which formally incorporates data from a previous randomized Phase 2b study (Protocol 2014-01, NCT02299570) of RBX2660.
Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study treatment and at months 3 and 6. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.
Conditions Module
Conditions
Clostridium Difficile Infection (CDI)
Keywords
C Difficile Colitis
Clostridium Difficile
CDI
C.Difficile Diarrhea
Fecal Transplant
Fecal Microbiota Transplant (FMT)
Microbiota Restoration Therapy
Diarrhea
FMT
Microbial Suspension
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
320Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo is an suspension of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Drug: Placebo
Drug: Open label RBX2660 (only for confirmed CDI recurrence)
RBX2660
Experimental
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant
Drug: RBX2660
Drug: Open label RBX2660 (only for confirmed CDI recurrence)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RBX2660
Drug
RBX2660 is a rectally administered microbiota suspension
RBX2660
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy of RBX2660 Compared to Placebo Through 8 Weeks
The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.
8 weeks after completing the study treatment
Secondary Outcomes
Measure
Description
Time Frame
Sustained Clinical Response Through 6 Months After Blinded Treatment
The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old.
Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.
[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]
Exclusion Criteria:
Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
Previous fecal transplant
History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
An absolute neutrophil count of <1000 cells/µL during screening.
Pregnant, breastfeeding, or intends to become pregnant during study participation.
Bakken JS. Feces transplantation for recurrent Clostridium difficile infection: US experience and recommendations. Microb Ecol Health Dis. 2015 May 29;26:27657. doi: 10.3402/mehd.v26.27657. eCollection 2015. No abstract available.
EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.
See Also Links
Label
URL
Centers for Disease Control page last reviewed March 15, 2021; accessed March 01, 2022.
A total of 320 subjects were enrolled (signed consent) of which 31 were screen failures.
289 subjects were randomized: 193 to RBX2660 and 96 to placebo. Of the 289, 22 did not receive the allocated treatment.
Therefore, a total of 267 subjects were randomized and treated: 180 subjects were treated with blinded RBX2660 treatment and 87 subjects were treated with blinded Placebo treatment.
Recruitment Details
Recruitment was from July 2017 to February 2020 at 44 medical clinics in the United States and Canada. Recruitment was performed by trained investigators and study coordinators.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo: Placebo is normal saline solution administered rectally
FG001
RBX2660
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 6, 2019
May 3, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
microbiota suspension
Placebo
Drug
Placebo is normal saline solution administered rectally
Placebo
saline solution
Open label RBX2660 (only for confirmed CDI recurrence)
Drug
RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
Miller MA, Louie T, Mullane K, Weiss K, Lentnek A, Golan Y, Kean Y, Sears P. Derivation and validation of a simple clinical bedside score (ATLAS) for Clostridium difficile infection which predicts response to therapy. BMC Infect Dis. 2013 Mar 25;13:148. doi: 10.1186/1471-2334-13-148.
Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Ther Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.
Mishra R, Harvey A, Guo A, Tillotson G, Feuerstadt P, Khanna S, Shannon WD, Blount KF. Microbiome and metabolome changes after fecal microbiota, live-jslm, administration are associated with health-related quality of life improvements. Anaerobe. 2025 Dec;96:103006. doi: 10.1016/j.anaerobe.2025.103006. Epub 2025 Oct 18.
Feuerstadt P, Allegretti JR, Dubberke ER, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Tillotson G, Bancke LL, LaPlante K, Garey KW, Khanna S. Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection. Infect Dis Ther. 2024 Jan;13(1):221-236. doi: 10.1007/s40121-023-00907-w. Epub 2024 Jan 18.
Garey KW, Dubberke ER, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Wang H, Tillotson GS, Bancke LL, Feuerstadt P. Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial. Open Forum Infect Dis. 2023 Jul 20;10(8):ofad383. doi: 10.1093/ofid/ofad383. eCollection 2023 Aug.
Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, Aguilar H, Garcia-Diaz J, Wang GP, Berry SM, Marion J, Su X, Braun T, Bancke L, Feuerstadt P. Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs. 2022 Oct;82(15):1527-1538. doi: 10.1007/s40265-022-01797-x. Epub 2022 Oct 26.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant
RBX2660: RBX2660 is a microbiota suspension administered rectally
FG00087 subjects
FG001180 subjects
COMPLETED
FG00075 subjects
FG001159 subjects
NOT COMPLETED
FG00012 subjects
FG00121 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo: Placebo is normal saline solution administered rectally
BG001
RBX2660
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660: RBX2660 is a microbiota suspension administered rectally
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00087
BG001180
BG002267
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.7± 15.95
BG00161.3± 16.81
BG002
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00060.0(26 to 86)
BG00164.0(19 to 93)
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00060
BG001123
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG00026
BG00151
BG002
Clostridioides difficile infection (CDI) History
Number of CDI Episodes before Blinded Treatment
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=3
BG00059
BG001111
BG002
Antibiotic Screening
Antibiotics taken for qualifying CDI event prior to Blinded Treatment
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Vancomycin alone
BG00078
BG001157
BG002
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
Efficacy of RBX2660 Compared to Placebo Through 8 Weeks
The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.
The modified Intent-To-Treat (mITT) Population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.
Posted
Number
95% Confidence Interval
Model-estimated percent of participants
8 weeks after completing the study treatment
ID
Title
Description
OG000
Placebo
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo: Placebo is normal saline solution administered rectally
OG001
RBX2660
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660: RBX2660 is a microbiota suspension administered rectally
Units
Counts
Participants
OG00085
OG001177
Title
Denominators
Categories
Title
Measurements
OG00057.5(48.1 to 67.1)
OG00170.6(64.1 to 76.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.
Treatment Difference
13.1
2-Sided
95
2.3
24.0
The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).
Secondary
Sustained Clinical Response Through 6 Months After Blinded Treatment
The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure
The mITT population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.
Posted
Count of Participants
Participants
6 months after completing the study treatment
ID
Title
Description
OG000
Placebo
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo: Placebo is normal saline solution administered rectally
OG001
RBX2660
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660: RBX2660 is a microbiota suspension administered rectally
Time Frame
Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660.
Description
Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Only
Placebo randomized subjects who did not receive an unblinded RBX2660.
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo: Placebo is normal saline solution administered rectally
0
63
5
63
23
63
EG001
RBX2660 Only
RBX2660 randomized subjects who did not receive an unblinded RBX2660.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660: RBX2660 is a microbiota suspension administered rectally
Placebo randomized subjects who went on to receive an unblinded RBX2660 (blinded period).
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (blinded period).
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
Placebo randomized subjects who went on to receive an unblinded RBX2660 (open-label period).
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (open-label period).
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
1
41
5
41
19
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected41 at risk
EG0040 events0 affected24 at risk
EG0051 events1 affected41 at risk
Cardio-respiratory arrest
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0012 events2 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0012 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Gastritis alcoholic
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Multimorbidity
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0012 events2 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0011 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0013 events1 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected139 at risk
EG0020 events0 affected24 at risk
EG003
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)