anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Strontium acetate
Trial phase: Phase 3
SMILES: CC(=O)[O-].CC(=O)[O-].[Sr+2]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 140
Group description: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

8% Strontium Acetate: Tubular occluding formulation
Eligibility criteria:
Inclusion Criteria:

Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.

Exclusion Criteria:

Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
Localized or generalized gingivitis or pulpitis with heavy calculus
Periodontal surgery in the preceding three months
Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.
Pregnant or breastfeeding females.
Intervention: SODIUM FLUORIDE
Trial phase: Phase 3
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 140
Group description: Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Sodium Fluoride: No claim of relieving Dentin Hypersensitivity
Eligibility criteria:
Inclusion Criteria:

Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.

Exclusion Criteria:

Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
Localized or generalized gingivitis or pulpitis with heavy calculus
Periodontal surgery in the preceding three months
Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.
Pregnant or breastfeeding females.
Intervention: Invokana
Trial phase: Phase 3
SMILES: Cc1ccc(C2OC(CO)C(O)C(O)C2O)cc1Cc1ccc(-c2ccc(F)cc2)s1.Cc1ccc(C2OC(CO)C(O)C(O)C2O)cc1Cc1ccc(-c2ccc(F)cc2)s1.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

- Have clinically stable symptomatic heart failure (HF) (heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]): (A) For HFrEF: (a) ejection fraction (EF) less than or equal to (<=) 40 percent (%) and (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or eplerenone (mineralocorticoid receptor antagonists), in the past 18 months

Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of less than or equal to (<=) 80 prior to randomization
Be able to read and understand English
Possess and have sole use (example: not shared with other users) of smartphone compatible with the Fitbit device
Willing/able to wear the Fitbit device on a regular basis for the 9-month study period

Exclusion Criteria:

Currently taking a sodium-glucose co-transporter 2 inhibitor (SGLT2i) or within the last 3 months
History of diabetic ketoacidosis or have type 1 diabetes mellitus (T1DM)
Have acute decompensated HF (exacerbation of symptomatic HF) requiring intravenous diuretics, inotropes, or vasodilators within the last 4 weeks
Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration rate [eGFR] <30 milliliter per minute [ml/min] on dialysis) from the most recent assessment
Have a diagnosis of hypotension within 30 days
Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Paracervical block with 18mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate plus 0.15mg of buprenorphine

Buprenorphine 0.15 MG: Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
Eligibility criteria:
Inclusion Criteria:

Gestational age 14 0/7 weeks to 23 6/7 weeks at time of osmotic dilator insertion
Require cervical preparation with placement of osmotic dilators
At least 18 years of age
Fluent in English or Spanish

Exclusion Criteria:

Same day dilation and evacuation procedure
Request for sedation during osmotic dilator insertion
Liver disease
Allergy to buprenorphine, lidocaine, or ibuprofen
Narcotic or opioid medication use in the preceding 24 hours
Use of recreational/illicit medications in the preceding 24 hours
Currently incarcerated
Intervention: Edaravone
Trial phase: Phase 1
ATC code: N07XX14
SMILES: CC1=NN(c2ccccc2)C(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
Eligibility criteria:
Inclusion Criteria:

The key criteria are listed below.

Patients aged between 20 and 80 years at the time of informed consent
Japanese patients
Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
ALS Patients with gastrostomy
Patients who can consent to contraception
Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
Patients undergoing treatment for malignancy.
Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg
Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
Intervention: Tacrolimus
Trial phase: Phase 3
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Tacrolimus as maintenance immunosuppression

Tacrolimus: Low dose Tacrolimus
Eligibility criteria:
Inclusion Criteria:

Liver transplant recipients ≥ 18 years old
Baseline renal dysfunction (GFR ≤ 60 mL/min)
Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 3 - 5 mg/kg)
Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis

Exclusion Criteria:

Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation
Incompletely healed incision or other wound healing issues at time of randomization
Multiple or previous organ transplantation
Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 mo prior to transplantation
Insurance company unwilling to pay for the cost of the everolimus
Pregnant women
Unable to provide informed consent
Intervention: Everolimus
Trial phase: Phase 3
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Everolimus as maintenance immunosuppression

Everolimus: Everolimus
Eligibility criteria:
Inclusion Criteria:

Liver transplant recipients ≥ 18 years old
Baseline renal dysfunction (GFR ≤ 60 mL/min)
Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 3 - 5 mg/kg)
Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis

Exclusion Criteria:

Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation
Incompletely healed incision or other wound healing issues at time of randomization
Multiple or previous organ transplantation
Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 mo prior to transplantation
Insurance company unwilling to pay for the cost of the everolimus
Pregnant women
Unable to provide informed consent
Intervention: Humulin N
Trial phase: Not Applicable
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.

Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates
Eligibility criteria:
Inclusion Criteria:

Adults ≥18 years of age
Diagnosis of T1DM for > 1 year
On MDI with decision made to commence CSII
Structured education in previous 3 years
HbA1c ≤ 75mmol/mol (9%)
Stimulated c-peptide <200pmol/L
No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

Previous CSII
Night or shift worker
Recurrent severe hypoglycaemia
Pregnant or planning pregnancy
Breastfeeding
Enrolled in other clinical trials
Have active malignancy or under investigation for malignancy
Addison's Disease
Gastroparesis
Autonomic neuropathy
Concomitant use of GLP-1 analogues and gliptins
Visual impairment
Reduced manual dexterity
Intervention: Humulin N
Trial phase: Not Applicable
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: flat basal rate

Insulin (flat rate): Participant's own insulin set to flat basal rates
Eligibility criteria:
Inclusion Criteria:

Adults ≥18 years of age
Diagnosis of T1DM for > 1 year
On MDI with decision made to commence CSII
Structured education in previous 3 years
HbA1c ≤ 75mmol/mol (9%)
Stimulated c-peptide <200pmol/L
No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

Previous CSII
Night or shift worker
Recurrent severe hypoglycaemia
Pregnant or planning pregnancy
Breastfeeding
Enrolled in other clinical trials
Have active malignancy or under investigation for malignancy
Addison's Disease
Gastroparesis
Autonomic neuropathy
Concomitant use of GLP-1 analogues and gliptins
Visual impairment
Reduced manual dexterity
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days.

Ferric carboxymaltose: IV iron
Eligibility criteria:
Inclusion Criteria:

Unsatisfactory response to oral iron or those that required a concomitant intervention, (defined as, blood transfusion, use of IV or oral iron outside of protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study protocol 1VIT17044], change in IBD treatment).
Hgb <11 g/dL
Ferritin ≤300 ng/mL and TSAT <30%

Exclusion Criteria:

Known history of hypersensitivity reaction to any component of FCM.
History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, in the opinion of the investigator, may place a subject at added risk for participation in the study.
Any existing non-viral infection.
Known history of positive HBsAg or HCV with evidence of active hepatitis.
Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).
Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected.
Administration and / or use of an investigational product (drug or device) within 30 days of screening.
Alcohol or drug abuse within the past six months.
Female participant who is pregnant or lactating, or sexually active females who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.
Unable to comply with study procedures and assessments.
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 246
Group description: AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:

Decreased sexual desire or libido
Decreased spontaneous erections (e.g. morning erections)
Decreased energy or fatigue/feeling tired
Low mood or depressed mood
Loss of body (axillary and pubic) hair or reduced shaving
Hot flashes AND
Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
Blood pressure >100/60 mmHg and <140/90 mmHg

Exclusion Criteria:

Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
Prostate or breast cancer
Any active malignancy
Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
Intervention: Oraqix
Trial phase: Not Applicable
SMILES: CCCNC(C)C(=O)Nc1ccccc1C.CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 354
Group description: Use EMLA cream in the management of peripheral venipuncture pain.

EMLA cream will be applied on the skin surface of the injection site, 30 minutes prior to procedure. The dosage is 1g per square centimeter.
Eligibility criteria:
Inclusion Criteria:

Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.

Exclusion Criteria:

Emergency peripheral intravenous puncture.
Allergic history for lidocaine cream.
Presence of cognitive impairment, hearing impairment or visual impairment.
Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
Refuse to participate in the study.
Intervention: Humalog
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
Eligibility criteria:
Inclusion Criteria:

Male or female participants with type 1 diabetes
Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial

Exclusion Criteria:

Known or suspected hypersensitivity to investigational medical product(s) or related products
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
Widespread subcutaneous lipodystrophy in the abdomen
Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
Chronic or recent use of corticosteroids
Intervention: Trofinetide
Trial phase: Phase 3
SMILES: C[C@@]1(C(=O)N[C@@H](CCC(=O)O)C(=O)O)CCCN1C(=O)CN
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 154
Group description: All subjects enrolled and treated with trofinetide
Eligibility criteria:
Inclusion Criteria:

Has completed the Week 12/End-of-treatment visit of the antecedent study, Study ACP-2566-003
Met all entry criteria for the antecedent study
May benefit from long-term treatment with open-label trofinetide in the judgment of the Investigator
Can still swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Baseline

Exclusion Criteria:

Began treatment with growth hormone during the antecedent study
Began treatment with IGF-1 during the antecedent study
Began treatment with insulin during the antecedent study
Has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study
Has a clinically significant abnormality in vital signs at Baseline
Has a QTcF interval of >450 ms on the Baseline ECG performed before the first dose of trofinetide is given in the present study
Has developed a clinically significant ECG finding during the antecedent study

Additional inclusion/exclusion criteria apply. Patients will be evaluated at baseline to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).