anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tenapanor
Trial phase: Phase 3
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 293
Group description: Tenapanor, 50mg BID (100mg total)

Tenapanor
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 to 75 years, inclusive
Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
A colonoscopy based on AGA guidelines; every 10 years at ≥50 years old

Exclusion Criteria:

Functional diarrhea as defined by Rome III criteria
IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome.
Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine >2 mg/dL)
Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
Any surgery on the stomach, small intestine or colon, excluding appendectomy and cholecystectomy (unless within 60 days of screening visit)
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 96
Group description: Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily

vitamin D3 4000 IU: The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap.
Eligibility criteria:
Inclusion Criteria:

6 to 16 years old
Physician-diagnosed asthma for at least one year
At least one severe asthma exacerbation in the previous year
Use of asthma medications (daily controller medication [ICS or leukotriene inhibitor] or inhaled β2-agonist [at least three days per week]) for at least six months in the previous year
Vitamin D insufficiency (i.e., serum vitamin D (25(OH)D level <30 ng/ml (75 nmol/L))
FEV1 ≥70 % of predicted
Positive bronchodilator response (i.e., increase in FEV1 ≥8% from baseline after inhaled short acting beta agonist or increased airway responsiveness to methacholine (PC20 ≤8 mg/ml if not on ICS or PC20 ≤16 mg/ml if on ICS)
Study protocol (i.e., age-appropriate dose of Fluticasone and no other asthma controller medications) approved by the child's regular doctor
Parental consent and child's assent to participate in the study.

Additional inclusion criteria applied after the run-in period, to be eligible for randomization:

Adherence with ICS and study medication (≥75% use [at least 21 of 28 days]) during the run-in period
Willingness to be randomized and complete study

Exclusion Criteria:

Serum calcium >10.8 mg/dl
Serum 25(OH) D <14 ng/ml (35 nmol/L)
Chronic respiratory disorder other than asthma
Severe asthma (intubation for asthma at any time OR ≥3 hospitalizations for asthma in previous year OR ≥6 severe asthma exacerbations in previous year)
Hepatic/renal disease, rickets, malabsorption, or other diseases that would affect vitamin D metabolism
Current smoking, or former smoking if ≥5 pack-years
Immune deficiency, cleft palate or Down's syndrome
Treatment with anticonvulsants or ≥1,000 IU/day of vitamin D2 or D3
Chronic oral corticosteroid therapy
Inability to perform acceptable spirometry
Use of investigational therapies or participation in trials 30 days before or during the study
Participant is currently breast feeding an infant
Pregnancy
Weight less than 10 kg
Plans to move out of the study site area in the next year

Additional exclusion criteria applied after the run-in period:

Any severe asthma exacerbation during the run-in period
Need for asthma medications other than ICS and p.r.n. rescue inhalers during the run-in period
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 3
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Formulations:

PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron

Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.

Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.
Eligibility criteria:
Inclusion Criteria:

Subjects 0 to <18 years at time of consent.
Subjects with hyperphosphataemia
Subjects ≥1 year with CKD Stages 4-5 defined by a glomerular filtration rate <30 mL/min/1.73 m2 or with CKD Stage 5D receiving adequate maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 2 months prior to screening.
Subjects <1 year must have CKD.
Appropriate written informed consent and, where appropriate/required assent, have been provided.

Exclusion Criteria:

Subjects with hypercalcaemia at screening
Subjects with intact parathyroid hormone (iPTH) levels >700 pg/mL at screening.
Subjects who are PB naïve who weigh <5 kg at screening. Subjects receiving stable doses of PBs who weigh <6 kg at screening
Subjects requiring feeding tube sizes ≤6 FR (French catheter scale).
Subjects with history of major gastrointestinal surgery or significant gastrointestinal disorders.
Subjects with hypocalcaemia (serum total corrected calcium <1.9 mmol/L; <7.6 mg/dL) at screening.
Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
Subject has a significant medical condition(s)
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 0.5%-2% sevoflurane

sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis intracranial aneurysm surgery ,
American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

Exclusion Criteria:

severe hepatic and renal dysfunction
coagulation disorder
taking antioxidant perioperative period
Intervention: Estradiol
Trial phase: Not Applicable
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.

Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Menopausal with absence of menstruation for at least 12 months
Presence of vaginal atrophy symptoms [subjective assessment of vaginal dryness >7cm on VAS)
Prolapse stage < II, according to the pelvic organ prolapse quantification (POP-Q) system[31]
No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included after 2 weeks)
Understanding and acceptance of the obligation to return for all scheduled follow-up visits

Exclusion Criteria:

Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation
Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida).
Personal history of Scleroderma
Any serious disease, or chronic condition, that could interfere with the study compliance
Previously undergone reconstructive pelvic surgery within the past 6 months
Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless current untreated exposure or extrusion)
Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the study
Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
Personal history of thrombophlebitis
Personal history of heart failure or myocardial infarction within 12 months of procedure
Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
Taking medications that are photosensitive
Contraindication to Vaginal Estrogen Therapy
Unwilling to Take Vaginal Estrogen
Inability to give informed consent
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)

Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
Eligibility criteria:
Inclusion Criteria:

All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at least 2 of the following criteria:

(i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

Patients with SIRS (≥ 2 of the following criteria: temperature <36°C or >38°C, heart rate >90/min, respiratory rate >20/min OR PaCO2<32 mmHg, WBC <4,000/mm3, >12,000/mm3 or >10% bands) upon hospital admission or who develop SIRS during their first week of hospitalization

Exclusion Criteria:

Presence of OF (shock defined by SBP<90mmHg, PO2<60mmHg on room air or need for mechanical ventilation, Cr≥2mg/dL)
Presence of renal dysfunction (Cr>1.5mg/dL)
Active peptic ulcer disease
Pregnancy
Use of daily NSAIDs within 1 week of presentation
Allergy to NSAIDs.
Intervention: Fidaxomicin
Trial phase: Phase 4
ATC code: A07AA12
SMILES: CCc1c(Cl)c(O)c(Cl)c(O)c1C(=O)OC1C(C)OC(OCC2=CC=CCC(O)C(C)=CC(CC)C(OC3OC(C)(C)C(OC(=O)C(C)C)C(O)C3O)C(C)=CC(C)=CCC(C(C)O)OC2=O)C(OC)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years of age or older with >3 unformed stools/24 hours with positive stool test for C. difficile.

Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.

High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations

Medium risk: 1st generation cephalosporin, macrolides*, and aztreonam

*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection

Exclusion Criteria:

Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
Patients with an allergy to oral vancomycin or fidaxomicin.
Patients anticipated to receive metronidazole after enrollment.
Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for > 24 hours within the preceding 72 hours at the time of enrollment.
Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.

Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:

Patients have had a recent dose adjustment;
Baseline number of bowel movement while on laxatives is unknown.
Number of bowel movements and/or consistency has not changed from baseline.
Patients who have had colostomy or ileostomy
Patients who will have colostomy or ileostomy after enrollment and before study ends
Patients who are or will be on long-term (>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Intervention: Vancomycin
Trial phase: Phase 4
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years of age or older with >3 unformed stools/24 hours with positive stool test for C. difficile.

Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.

High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations

Medium risk: 1st generation cephalosporin, macrolides*, and aztreonam

*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection

Exclusion Criteria:

Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
Patients with an allergy to oral vancomycin or fidaxomicin.
Patients anticipated to receive metronidazole after enrollment.
Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for > 24 hours within the preceding 72 hours at the time of enrollment.
Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.

Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:

Patients have had a recent dose adjustment;
Baseline number of bowel movement while on laxatives is unknown.
Number of bowel movements and/or consistency has not changed from baseline.
Patients who have had colostomy or ileostomy
Patients who will have colostomy or ileostomy after enrollment and before study ends
Patients who are or will be on long-term (>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, at least 18 years of age at time of screening.
Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection.
Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening.
Subjects must be documented as non-cirrhotic.
Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine.

Exclusion Criteria:

Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
Clinical history of fibrosing cholestatic hepatitis post-transplant.
Re-transplantation of the liver or kidney.
Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
History of post-transplant complications related to hepatic or renal vasculature.
Intervention: Semaglutide
Trial phase: Phase 3
ATC code: A10BJ06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)C(C)(C)NC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1591
Group description: Participants were to take once-daily semaglutide tablets in a dose escalation manner for upto 82 weeks: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 9 to upto week 82.
Eligibility criteria:
Inclusion Criteria:

Male or female diagnosed with type 2 diabetes
Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion Criteria:

Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2)
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
Intervention: NORETHINDRONE
Trial phase: Phase 4
ATC code: G03AC01 | G03DC02 | G03FA01
SMILES: C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks

Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg
Eligibility criteria:
Inclusion Criteria:

28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.

Exclusion Criteria:

History of hysterectomy, oophorectomy or both
History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis
History of bone disease including non-traumatic vertebral fractures on radiography
Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C >8, uncontrolled hypertension defined as a systolic blood pressure >160 mmHg, awaiting organ transplant)
Previous or current cancer, excluding basal cell carcinoma
Previous or current thromboembolic disease
Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)
Current or previous use of HRT within the past 3 months
Current or recent (<12 months) substance abuse, including tobacco use
No drug interactions with HRT
No racial or ethnic groups will be excluded
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 276
Group description: Administered as a coated bilayer tablet

Olanzapine: Daily dosing
Eligibility criteria:
Inclusion Criteria:

Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
Additional criteria may apply

Exclusion Criteria:

Subject has any of the following psychiatric conditions per DSM-5 criteria:
Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
Drug-induced or toxic psychosis
Any other psychiatric condition that could interfere with participation in the study
Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
Additional criteria may apply