## Protocol Section
### Identification Module
**NCT ID:** NCT02476279

**Acronym:** SVI

**Brief Title:** Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis

**Official Title:** Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial

#### Organization Study ID Info
**ID:** U01DK104833-01
**Link:** https://reporter.nih.gov/quickSearch/U01DK104833-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
#### Secondary ID Infos
**ID:** U01DK104833-01
**Link:** https://reporter.nih.gov/quickSearch/U01DK104833-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2023-01-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-01-25

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-05-08

**Type:** ACTUAL

**Results First Submit Date:** 2024-04-15

**Results First Submit QC Date:** 2024-04-15

#### Start Date
**Date:** 2015-09

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2015-06-19
**Type:** ESTIMATED
**Study First Submit Date:** 2015-06-15
**Study First Submit QC Date:** 2015-06-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Investigator Affiliation:** Medical University of South Carolina

**Investigator Full Name:** Badih Joseph Elmunzer

**Investigator Title:** Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. The investigators recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (\>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized.

Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases.

Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, the investigators will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.

**Detailed Description:** The purpose of the SVI study is to determine whether or not rectal indomethacin has no important loss of efficacy as compared to the combination of rectal indomethacin and prophylactic pancreatic stent placement in patients undergoing high-risk ERCP who require pancreatic stent placement (PSP) for the sole purpose of pancreatitis prevention. The primary efficacy endpoint is defined as post-ERCP pancreatitis defined per consensus (Altanta) criteria. Another way of stating the trial's purpose is that the proportion of subjects with post-ERCP pancreatitis on rectal indomethacin alone is not more than that of the combination of rectal indomethacin and prophylactic PSP by more than a pre-specified absolute amount (i.e., the non-inferiority margin).

This is a blinded, two-armed non-inferiority trial where eligible patients will be randomized to either the combination treatment or indomethacin alone. Participants will be randomized during the ERCP procedure after eligibility is confirmed, and receive indomethacin at the time of randomization. The primary efficacy endpoint of post-ERCP pancreatitis within 2 days from randomization will be assessed by an independent adjudication panel. The participant follow-up period is 30 days from randomization.

### Conditions Module

**Conditions:**

- Post-ERCP Pancreatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1950

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Indomethacin 100 mg rectally immediately after ERCP

**Intervention Names:**

- Other: Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement

**Label:** Indomethacin alone

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement

**Intervention Names:**

- Other: Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement

**Label:** Indomethacin+pancreatic stent

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Indomethacin alone

**Name:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Indomethacin+pancreatic stent

**Name:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Post-ERCP pancreatitis (PEP) was based on a widely validated consensus definition that was applied as a diagnostic framework. In this consensus definition, PEP is diagnosed if there was new onset (or increase) of pain in the upper abdomen, elevation in pancreatic enzymes of at least three times the upper limit of normal 24 h after the procedure, and hospitalization for at least two nights. The outcome was independently adjudicated by 3 ERCP experts at non-enrolling centers based on review of the medical records for study participants who were hospitalized with any adverse event within 2 days of the ERCP. Medical records were redacted of all information that could potentially reveal study group assignment, including radiology reports. The consensus definition was applied as a diagnostic framework so that adjudicators could use their best judgment in cases that did not strictly satisfy the criteria. PEP was declared if there was agreement between at least two of the three adjudicators.

**Measure:** The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis

**Time Frame:** Within 48 hours after ERCP

#### Secondary Outcomes

**Description:** Moderate or severe post-ERCP pancreatitis was based on the consensus definition as a diagnostic framework. For the severity assessment, radiographic information was made available to the adjudicators. The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. The outcome was declared if there was agreement between at least two of the three adjudicators.

**Measure:** The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis

**Time Frame:** Within one month of ERCP

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Any patient undergoing ERCP in whom pancreatic stent placement is planned for post-ERCP pancreatitis prevention, is ≥ 18 years old, who provides informed consent, AND:

Has one of the following:

1. Clinical suspicion of or known sphincter of Oddi dysfunction
2. History of post-ERCP pancreatitis (at least one prior episode of pancreatitis after ERCP)
3. Pancreatic sphincterotomy
4. Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy)
5. Difficult cannulation: cannulation duration ≥ 6 minutes (starting at time of initial papillary engagement with at least 25% of the time in contact with the papilla) AND/OR ≥ 6 cannulation attempts (defined as sustained contact with papilla lasting at least 1 second).
6. Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter.

   Or has at least 2 of the following:
7. Age \< 50 years old \& female gender
8. History of recurrent pancreatitis (at least 2 episodes)
9. ≥3 pancreatic injections
10. Pancreatic acinarization
11. Pancreatic brush cytology

Exclusion Criteria:

1. Ampullectomy
2. Cases in which a pancreatic stent must be placed for therapeutic intent
3. Unwillingness or inability to consent for the study
4. Pregnancy
5. Breast feeding mother
6. Standard contraindications to ERCP
7. Allergy to Aspirin or NSAIDs
8. Known renal failure (Cr \> 1.4 mg/dl)
9. Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage
10. Ongoing or recent (within 1 week) hospitalization for acute pancreatitis
11. Known chronic calcific pancreatitis
12. Pancreatic head malignancy
13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (no manipulation of minor papilla)
14. ERCP for biliary stent removal or exchange without anticipated pancreatogram
15. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
16. Anticipated inability to follow protocol
17. Absence of rectum

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Univesrity of Southern California

**State:** California

**Location 2:**

**City:** Denver

**Country:** United States

**Facility:** University of Colorado

**State:** Colorado

**Location 3:**

**City:** Orlando

**Country:** United States

**Facility:** The Florida Hospital

**State:** Florida

**Location 4:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University

**State:** Georgia

**Location 5:**

**City:** Chicago

**Country:** United States

**Facility:** Northwestern University

**State:** Illinois

**Location 6:**

**City:** Kansas City

**Country:** United States

**Facility:** University of Kansas

**State:** Kansas

**Location 7:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins University

**State:** Maryland

**Location 8:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Location 9:**

**City:** Saint Louis

**Country:** United States

**Facility:** Washington University

**State:** Missouri

**Location 10:**

**City:** Lebanon

**Country:** United States

**Facility:** Dartmouth University

**State:** New Hampshire

**Location 11:**

**City:** Cleveland

**Country:** United States

**Facility:** Case Western Reserve University

**State:** Ohio

**Location 12:**

**City:** Columbus

**Country:** United States

**Facility:** The Ohio State University Wexner Medical Center

**State:** Ohio

**Location 13:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health & Science University

**State:** Oregon

**Location 14:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh

**State:** Pennsylvania

**Location 15:**

**City:** Charleston

**Country:** United States

**Facility:** Medical University of South Carolina

**State:** South Carolina

**Location 16:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University

**State:** Tennessee

**Location 17:**

**City:** Seattle

**Country:** United States

**Facility:** Virginia Mason Medical Center

**State:** Washington

**Location 18:**

**City:** Milwaukee

**Country:** United States

**Facility:** Medical College of Wisconsin

**State:** Wisconsin

**Location 19:**

**City:** Calgary

**Country:** Canada

**Facility:** University of Calgary

**Location 20:**

**City:** Montreal

**Country:** Canada

**Facility:** McGill University

### References Module

#### References

**Citation:** Elmunzer BJ, Serrano J, Chak A, Edmundowicz SA, Papachristou GI, Scheiman JM, Singh VK, Varadarajulu S, Vargo JJ, Willingham FF, Baron TH, Cote GA, Romagnuolo J, Wood-Williams A, Depue EK, Spitzer RL, Spino C, Foster LD, Durkalski V; SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials. 2016 Mar 3;17(1):120. doi: 10.1186/s13063-016-1251-2. Erratum In: Trials. 2020 Jun 3;21(1):471.

**PMID:** 26941086

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-02-15

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 418360

- Type Abbrev: Prot

- Upload Date: 2024-03-18T13:07

- Date: 2020-01-03

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 585440

- Type Abbrev: SAP

- Upload Date: 2024-03-18T13:11

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13115

- Name: Pancreatitis

- Relevance: HIGH

- As Found: Pancreatitis

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010195

- Term: Pancreatitis

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000006074

- Term: Gout Suppressants

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10257

- Name: Indomethacin

- Relevance: HIGH

- As Found: Noise

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007213

- Term: Indomethacin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.

#### Event Groups

**Group ID:** EG000

**Title:** Indomethacin Alone

**Deaths Num Affected:** 24

**Deaths Num At Risk:** 975

**Description:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement

**ID:** EG000

**Other Num Affected:** 233

**Other Num at Risk:** 975

**Serious Number Affected:** 355

**Serious Number At Risk:** 975

**Title:** Indomethacin Alone

**Group ID:** EG001

**Title:** Indomethacin+Pancreatic Stent

**Deaths Num Affected:** 26

**Deaths Num At Risk:** 975

**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement

**ID:** EG001

**Other Num Affected:** 228

**Other Num at Risk:** 975

**Serious Number Affected:** 352

**Serious Number At Risk:** 975

**Title:** Indomethacin+Pancreatic Stent

**Frequency Threshold:** 0.5

#### Other Events

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Term:** Coagulopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 4

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Sickle cell anaemia with crisis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Splenic haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Acute left ventricular failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Bundle branch block left

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Sinus bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Sinus tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 140

**Num At Risk:** 975

**Num Events:** 163

**Group ID:** EG001

**Num Affected:** 166

**Num At Risk:** 975

**Num Events:** 177

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Colitis ulcerative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Diverticulum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Duodenal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Duodenal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Faecaloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gastric haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 975

**Num Events:** 8

**Term:** Gastrointestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Haematochezia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Haemorrhagic necrotic pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Haemorrhoids

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Intestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Intra-abdominal haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Intra-abdominal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Localised intraabdominal fluid collection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Melaena

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 975

**Num Events:** 9

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 16

**Num At Risk:** 975

**Num Events:** 16

**Group ID:** EG001

**Num Affected:** 9

**Num At Risk:** 975

**Num Events:** 9

**Term:** Pancreatic fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pancreatic haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreatic mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreatic necrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreatitis haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreatitis necrotising

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 90

**Num At Risk:** 975

**Num Events:** 92

**Group ID:** EG001

**Num Affected:** 76

**Num At Risk:** 975

**Num Events:** 80

**Term:** Peritoneal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Proctalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Retroperitoneal haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 975

**Num Events:** 5

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Generalised oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hypothermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Multiple organ dysfunction syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Term:** Systemic inflammatory response syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Bile duct obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Bile duct stone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Biliary colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Biloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 975

**Num Events:** 11

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cholestasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cryptogenic cirrhosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Haemobilia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatic haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatorenal syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatotoxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 6

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Perforation bile duct

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Transplant rejection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Abdominal abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Abdominal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Biliary tract infection bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Corona virus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cytomegalovirus colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gallbladder abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gangrene

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gastrointestinal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hepatitis C

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Liver abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pancreas infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Pneumonia staphylococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Postoperative wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pyelonephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 975

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 975

**Num Events:** 5

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Streptococcal bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Anaemia postoperative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Burns second degree

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Clavicle fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Incisional hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Peripancreatic fluid collection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Post procedural bile leak

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 975

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Post procedural haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Postoperative ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Procedural pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Vascular pseudoaneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Vena cava injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Blood bilirubin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Coronavirus test positive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Liver function test increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Transaminases increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** White blood cell count increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Diabetes mellitus inadequate control

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Failure to thrive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Lactic acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Metabolic alkalosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Adenocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Adenocarcinoma pancreas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** B-cell lymphoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Bladder cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Cholangiocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 975

**Num Events:** 6

**Term:** Colon cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Colon cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Colorectal adenocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Colorectal cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Gastric cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatic cancer recurrent

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hepatocellular carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Lung neoplasm malignant

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Malignant peritoneal neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Metastases to central nervous system

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Metastatic neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Neoplasm malignant

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Oesophageal carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pancreatic carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Pancreatic carcinoma metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Tongue cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Metabolic encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Device dislocation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Product Issues

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Major depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Psychogenic seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 975

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 975

**Num Events:** 6

**Term:** Chronic kidney disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Renal impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Renal vein compression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Urinary retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Female genital tract fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Acute pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Acute respiratory distress syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 975

**Num Events:** 4

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Respiratory distress

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 3

**Term:** Tachypnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Pruritus generalised

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Cholecystectomy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Term:** Extubation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hepatectomy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 975

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Flushing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 975

**Num Events:** 4

**Term:** Hypovolaemic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Term:** Peripheral ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 975

**Term:** Shock haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 975

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 975

**Num Events:** 1

**Time Frame:** Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Units:** Participants

### Group

**ID:** BG000

**Title:** Indomethacin Alone

**Description:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement

### Group

**ID:** BG001

**Title:** Indomethacin+Pancreatic Stent

**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.4

**Value:** 55.6

#### Measurement

**Group ID:** BG001

**Spread:** 16.3

**Value:** 55.8

#### Measurement

**Group ID:** BG002

**Spread:** 16.4

**Value:** 55.7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 599

#### Measurement

**Group ID:** BG001

**Value:** 596

#### Measurement

**Group ID:** BG002

**Value:** 1195

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 376

#### Measurement

**Group ID:** BG001

**Value:** 379

#### Measurement

**Group ID:** BG002

**Value:** 755

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 99

#### Measurement

**Group ID:** BG002

**Value:** 200

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 866

#### Measurement

**Group ID:** BG001

**Value:** 871

#### Measurement

**Group ID:** BG002

**Value:** 1737

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 115

#### Measurement

**Group ID:** BG001

**Value:** 102

#### Measurement

**Group ID:** BG002

**Value:** 217

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 809

#### Measurement

**Group ID:** BG001

**Value:** 825

#### Measurement

**Group ID:** BG002

**Value:** 1634

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 43

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.8

**Value:** 28.6

#### Measurement

**Group ID:** BG001

**Spread:** 7.2

**Value:** 29.6

#### Measurement

**Group ID:** BG002

**Spread:** 7.0

**Value:** 29.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 972

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1947

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 363

#### Measurement

**Group ID:** BG001

**Value:** 366

#### Measurement

**Group ID:** BG002

**Value:** 729

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 868

**Group ID:** BG001

**Value:** 875

**Group ID:** BG002

**Value:** 1743

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 262

#### Measurement

**Group ID:** BG001

**Value:** 252

#### Measurement

**Group ID:** BG002

**Value:** 514

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 60

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 128

#### Measurement

**Group ID:** BG001

**Value:** 126

#### Measurement

**Group ID:** BG002

**Value:** 254

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 795

#### Measurement

**Group ID:** BG001

**Value:** 823

#### Measurement

**Group ID:** BG002

**Value:** 1618

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 112

#### Measurement

**Group ID:** BG001

**Value:** 100

#### Measurement

**Group ID:** BG002

**Value:** 212

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0

**Upper Limit:** 1

**Value:** 0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 0

**Upper Limit:** 2

**Value:** 1

#### Measurement

**Group ID:** BG002

**Lower Limit:** 0

**Upper Limit:** 2

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 973

**Group ID:** BG001

**Value:** 974

**Group ID:** BG002

**Value:** 1947

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 58

#### Measurement

**Group ID:** BG001

**Value:** 66

#### Measurement

**Group ID:** BG002

**Value:** 124

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 864

#### Measurement

**Group ID:** BG001

**Value:** 869

#### Measurement

**Group ID:** BG002

**Value:** 1733

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 555

#### Measurement

**Group ID:** BG001

**Value:** 546

#### Measurement

**Group ID:** BG002

**Value:** 1101

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 975

**Group ID:** BG001

**Value:** 975

**Group ID:** BG002

**Value:** 1950

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 935

**Value:** 1796

#### Measurement

**Group ID:** BG001

**Spread:** 938

**Value:** 1852

#### Measurement

**Group ID:** BG002

**Spread:** 937

**Value:** 1824

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 974

**Group ID:** BG001

**Value:** 974

**Group ID:** BG002

**Value:** 1948

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1052

**Value:** 1554

#### Measurement

**Group ID:** BG001

**Spread:** 1085

**Value:** 1606

#### Measurement

**Group ID:** BG002

**Spread:** 1069

**Value:** 1581

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 972

**Group ID:** BG001

**Value:** 973

**Group ID:** BG002

**Value:** 1945

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** 3 French

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 165

#### Measurement

**Group ID:** BG002

**Value:** 169

**Category Title:** 4 French

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 586

#### Measurement

**Group ID:** BG002

**Value:** 595

**Category Title:** 5 French

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** >5 French

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Missing

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 787

**Group ID:** BG002

**Value:** 803

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 455

#### Measurement

**Group ID:** BG002

**Value:** 462

**Category Title:** 2-5cm

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 95

#### Measurement

**Group ID:** BG002

**Value:** 98

**Category Title:** 6-8cm

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 237

#### Measurement

**Group ID:** BG002

**Value:** 240

**Category Title:** >8cm

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Missing

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 787

**Group ID:** BG002

**Value:** 803

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** BMI missing for 3 participants
**Title:** BMI
**Unit of Measure:** kg/m^2
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Missing in 207 patients (100 in indomethacin plus stent group, 107 in indomethacin alone group) due to question being added in August, 2016.
**Title:** Antibiotic use in past 3 months
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Clinical suspicion or known sphincter of Oddi dysfunction
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of post-ERCP pancreatitis
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of recurrent pancreatitis
**Unit of Measure:** Participants
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Difficult cannulation
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Precut (access) sphincterotomy
**Unit of Measure:** Participants
### Measure 12
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Population Description:** Missing in three patients (one in indomethacin plus stent group, two in indomethacin alone group).
**Title:** Number of pancreatic injections
**Unit of Measure:** injections
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Pancreatic sphincterotomy
**Unit of Measure:** Participants
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Pancreatic acinarisation
**Unit of Measure:** Participants
### Measure 15
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Biliary sphincterotomy
**Unit of Measure:** Participants
### Measure 16
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Trainee involvement
**Unit of Measure:** Participants
### Measure 17
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Missing in two patients (one in indomethacin plus stent group, one in indomethacin alone group).
**Title:** Total intravenous fluid received during periprocedural period, mL
**Unit of Measure:** mL
### Measure 18
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Missing in five patients (two in indomethacin plus stent group, three in indomethacin alone group).
**Title:** Total intravenous lactated Ringer's fluid received during periprocedural period, mL
**Unit of Measure:** mL
### Measure 19
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis population is those who received a stent
**Title:** Prophylactic pancreatic stent calibre in those who received a stent
**Unit of Measure:** Participants
### Measure 20
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis population is those who received a stent
**Title:** Prophylactic pancreatic stent length in those who received a stent
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Potential unmasking events occurred and could have influenced care. Decay in secondary outcome blinding, as unblinded clinician could resume care of patient after 48 h. Adjudicators provided radiographic information when assessing PEP severity, which may have influenced decision making. Unblinded endoscopists made procedural decisions, possibly altered according to study arm. Findings may not be applicable to community endoscopists since all sites were tertiary referral centers.
### Point of Contact
**Email:** elmunzer@musc.edu
**Organization:** Division of Gastroenterology & Hepatology, Medical University of South Carolina
**Phone:** 8437926982
**Title:** Dr. B. Joseph Elmunzer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.006
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.066
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.
**Group Description:** 
**Non-Inferiority Comment:** To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 0.036
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.003
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.060
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.
**Group Description:** 
**Non-Inferiority Comment:** To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 0.028
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -0.002
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.043
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 0.021
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.004
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.044
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 0.020
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 145
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 975
- **Group ID:** OG001
- **Value:** 975
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 137
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 951
- **Group ID:** OG001
- **Value:** 777
**Units:** Participants
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 974
- **Group ID:** OG001
- **Value:** 974
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 951
- **Group ID:** OG001
- **Value:** 777
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Post-ERCP pancreatitis (PEP) was based on a widely validated consensus definition that was applied as a diagnostic framework. In this consensus definition, PEP is diagnosed if there was new onset (or increase) of pain in the upper abdomen, elevation in pancreatic enzymes of at least three times the upper limit of normal 24 h after the procedure, and hospitalization for at least two nights. The outcome was independently adjudicated by 3 ERCP experts at non-enrolling centers based on review of the medical records for study participants who were hospitalized with any adverse event within 2 days of the ERCP. Medical records were redacted of all information that could potentially reveal study group assignment, including radiology reports. The consensus definition was applied as a diagnostic framework so that adjudicators could use their best judgment in cases that did not strictly satisfy the criteria. PEP was declared if there was agreement between at least two of the three adjudicators.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Intention-To-Treat and Per Protocol populations
**Reporting Status:** POSTED
**Time Frame:** Within 48 hours after ERCP
**Title:** The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement
**ID:** OG000
**Title:** Indomethacin Alone
##### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
**ID:** OG001
**Title:** Indomethacin+Pancreatic Stent
#### Outcome Measure 2
**Description:** Moderate or severe post-ERCP pancreatitis was based on the consensus definition as a diagnostic framework. For the severity assessment, radiographic information was made available to the adjudicators. The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. The outcome was declared if there was agreement between at least two of the three adjudicators.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Intention-to-treat and per protocol. Outcome data missing for two participants (one in each treatment arm) and excluded from percentage denominator.
**Reporting Status:** POSTED
**Time Frame:** Within one month of ERCP
**Title:** The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement
**ID:** OG000
**Title:** Indomethacin Alone
##### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
**ID:** OG001
**Title:** Indomethacin+Pancreatic Stent
### Participant Flow Module
#### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement
**ID:** FG000
**Title:** Indomethacin Alone
#### Group
**Description:** Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
**ID:** FG001
**Title:** Indomethacin+Pancreatic Stent
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 975
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 975
##### Milestone
**Type:** COMPLETED
**Comment:** Completed follow-up for the primary and secondary endpoints
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 974
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 974
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Pre-Assignment Details:** Of 7243 patients assessed for eligibility, 1950 met eligibility criteria and were randomly assigned to treatment.
**Recruitment Details:** Patients were recruited from 20 referral centers in the USA and Canada between September 2015 and January 2023.
**Has Results:** True