anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Augmentin
Trial phase: Phase 2
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 55
Group description: OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Eligibility criteria:
Inclusion Criteria includes but is not limited to:

Male and female infants and children aged ≥6 months to ≤24 months
Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of the TM
Score of 5 or more on the 5 question version of AOM-SOS scale1
Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol.
Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria includes but is not limited to:

Allergy to penicillin or cephalosporin
History or presence of immunodeficiency disorders
Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
Intervention: Velpatasvir
Trial phase: Phase 2
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to < 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.
Eligibility criteria:
Key Inclusion Criteria:

Consent of parent or legal guardian required
Chronic HCV infection
Screening laboratory values within defined thresholds

Individuals must have a determination of prior treatment status:

DAA-naive is defined as either:

Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA
Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)
Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)
Pregnant or nursing females
Known hypersensitivity to study medication
Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 75
Group description: Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective non-cardiac surgery
ASA physical status of 2 or 3
Age equal to or greater than 18 years old

Exclusion Criteria:

Adults unable to provide consent
Age less than 18 years old
Pregnant women
Prisoners
Difficult airway
Morbid Obesity
Preoperative sedation use
Severe Cardiac, pulmonary and liver disease
Hypotension and shock
Emergency surgeries
Allergy to propofol or etomidate
Intervention: Etomidate
Trial phase: Phase 4
ATC code: N01AX07
SMILES: CCOC(=O)c1cncn1[C@H](C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 75
Group description: Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective non-cardiac surgery
ASA physical status of 2 or 3
Age equal to or greater than 18 years old

Exclusion Criteria:

Adults unable to provide consent
Age less than 18 years old
Pregnant women
Prisoners
Difficult airway
Morbid Obesity
Preoperative sedation use
Severe Cardiac, pulmonary and liver disease
Hypotension and shock
Emergency surgeries
Allergy to propofol or etomidate
Intervention: Nintedanib
Trial phase: Phase 3
ATC code: L01EX09
SMILES: COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 434
Group description: Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
Eligibility criteria:
Inclusion Criteria:

Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
Previous enrolment in this trial. Further exclusion criteria apply.
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.

Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
Eligibility criteria:
Inclusion Criteria:

Age 18 and older
Primary diagnosis of rotator cuff tear
Able to provide informed consent
Is willing and able to accept text messages

Exclusion Criteria:

Known allergies to the study medications.
Known narcotic or alcohol abuse (< 3 months)
Revision rotator cuff surgery
Contraindication to regional anesthesia
Current narcotic regimen or contract with pain management specialist

Diagnosed with any of the following co-morbidities:

Pre-existing coagulation disorder
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline

liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:

Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
Eligibility criteria:
Inclusion Criteria:

Age 18 and older
Primary diagnosis of rotator cuff tear
Able to provide informed consent
Is willing and able to accept text messages

Exclusion Criteria:

Known allergies to the study medications.
Known narcotic or alcohol abuse (< 3 months)
Revision rotator cuff surgery
Contraindication to regional anesthesia
Current narcotic regimen or contract with pain management specialist

Diagnosed with any of the following co-morbidities:

Pre-existing coagulation disorder
Intervention: Miricorilant
Trial phase: Phase 2
SMILES: O=c1[nH]c(=O)c(Cc2cccc(C(F)(F)F)c2)c([C@H]2CC[C@H](c3ccccc3)CC2)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of NASH based on a biopsy obtained within the last year OR
Have a diagnosis of presumed NASH based on blood tests and scans

Exclusion Criteria:

Have participated in another clinical trial within the last year and received active treatment for NASH
Have participated in another clinical trial for any other indication within the last 3 months
Are pregnant or lactating women
Have a BMI <18 kg/m^2
Have had liver transplantation or plan to have liver transplantation during the study
Have type 1 diabetes or poorly controlled type 2 diabetes.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Lidocaine Hydrochloride infusion

The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
Eligibility criteria:
Inclusion Criteria:

Undergoing robotic assisted prostatectomy or robotic assisted partial nephrectomy at University of Missouri Hospital for prostate cancer or kidney mass
Age ≥ 18 years
ASA I-III

Exclusion Criteria:

Inability to obtain written informed consent
Allergy to lidocaine or other amide local anesthetics
Atrioventricular conduction blocks
CV instability and concomitant use of alpha agonists or beta blockers
Recent myocardial infarction (≤ 6 months ago)
Cardiac arrhythmia disorders
Stokes-Adams syndrome
Wolff-Parkinson-White syndrome
Seizure disorders
Liver failure or hepatic dysfunction
Significant renal disease with a serum creatinine ≥ 2 mg/dl
A family history of malignant hyperthermia
Current use of opioids or documented history of opioid abuse
Typically, have less than 3 bowel movement per week
Combined surgical cases that include robotic prostatectomy or robotic partial nephrectomy
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Normal saline

The control group received normal saline.
Eligibility criteria:
Inclusion Criteria:

Undergoing robotic assisted prostatectomy or robotic assisted partial nephrectomy at University of Missouri Hospital for prostate cancer or kidney mass
Age ≥ 18 years
ASA I-III

Exclusion Criteria:

Inability to obtain written informed consent
Allergy to lidocaine or other amide local anesthetics
Atrioventricular conduction blocks
CV instability and concomitant use of alpha agonists or beta blockers
Recent myocardial infarction (≤ 6 months ago)
Cardiac arrhythmia disorders
Stokes-Adams syndrome
Wolff-Parkinson-White syndrome
Seizure disorders
Liver failure or hepatic dysfunction
Significant renal disease with a serum creatinine ≥ 2 mg/dl
A family history of malignant hyperthermia
Current use of opioids or documented history of opioid abuse
Typically, have less than 3 bowel movement per week
Combined surgical cases that include robotic prostatectomy or robotic partial nephrectomy
Intervention: ASPIRIN
Trial phase: Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants received aspirin 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of relapsing-remitting MS
self-reported heat-sensitivity to exercise
Expanded Disability Status Scale (EDSS) total score ≤ 6.0
exacerbation-free (and no use of corticosteroids) for 6 weeks prior
BMI ≤ 40

Exclusion Criteria:

prior history of significant head injury, stroke, or other neurological disease/disorder
current daily use of antipyretics or pain medication
currently in a major depressive episode
vascular disease of the legs, uncontrolled high blood pressure
uncontrolled diabetes mellitus or problem with blood sugar levels
contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)
tarry stool or known fecal occult blood
uncontrolled syndrome of asthma, rhinitis, or nasal polyps
contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)
Intervention: Bimatoprost
Trial phase: Phase 3
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 236
Group description: Bimatoprost: Eyedrops
Eligibility criteria:
Inclusion Criteria:

Informed consent signed and dated.
Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

History of trauma, infection, clinically significant inflammation within the 3 previous months.
Uncontrolled diabetic patient.
Pregnancy or breast feeding.
Intervention: Bimatoprost
Trial phase: Phase 3
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: Lumigan®: Eyedrops
Eligibility criteria:
Inclusion Criteria:

Informed consent signed and dated.
Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

History of trauma, infection, clinically significant inflammation within the 3 previous months.
Uncontrolled diabetic patient.
Pregnancy or breast feeding.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: 1g TXA administered intravenous piggyback at start of surgery OR
1g TXA administered intravenous piggyback at start and at time of closure of surgery

Intravenous Tranexamic Acid: 1g TXA IVPB
Eligibility criteria:
Inclusion Criteria

All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

Exclusion Criteria for IV TXA administration

Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min
Severe ischemic heart disease
Color blindness or problems with color vision

Criteria for Use of Topical TXA

Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA

Absolute Exclusion Criteria

History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
Known congenital thrombophilia
History of thromboembolic or vascular disease
Disseminated intravascular coagulation (DIC)
History of seizures
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia (ASA) 1, 2, and 3
Ages 40-74
Patients scheduled for total shoulder replacement

Exclusion Criteria:

ASA 4 and 5
Pre-existing pain disorder
Regular consumption of chronic pain medication
pregnant women
any medical condition such as a clotting disorder
anatomic abnormality that precludes use of an indwelling scalene catheter
Body Mass Index (BMI) >40
Patient refusal
Pre-existing diabetic neuropathy or Hemoglobin A1c >9
Failed block
Intervention: Felcisetrag
Trial phase: Phase 2
SMILES: COC(=O)N1CCC(CN2CCC(CNC(=O)c3cccc4[nH]c(C(C)C)nc34)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
Eligibility criteria:
Inclusion Criteria:

Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.

Exclusion Criteria:

Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent [%]), has an active gastric pacemaker, or requires parenteral nutrition.
Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
Had a history of radiation therapy to the abdomen or pelvis.
Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Participants with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, participants with lesions not involving the rectum [sigmoid colon and above]).
Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.
Participant has known COVID-19 infection, or suspected COVID-19 infection.
Scheduled for abdominal surgery that is classified as emergency.
Intervention: Felcisetrag
Trial phase: Phase 2
SMILES: COC(=O)N1CCC(CN2CCC(CNC(=O)c3cccc4[nH]c(C(C)C)nc34)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
Eligibility criteria:
Inclusion Criteria:

Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.

Exclusion Criteria:

Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent [%]), has an active gastric pacemaker, or requires parenteral nutrition.
Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
Had a history of radiation therapy to the abdomen or pelvis.
Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Participants with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, participants with lesions not involving the rectum [sigmoid colon and above]).
Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.
Participant has known COVID-19 infection, or suspected COVID-19 infection.
Scheduled for abdominal surgery that is classified as emergency.