Adjunct Phentermine + Topiramate After Bariatric Surgery... | NCT04095104

ID	Type	Description	Link
5P30DK048520-24	U.S. NIH Grant/Contract		View source

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
University of Colorado- Clinical and Translational Sciences Institute	UNKNOWN
University of Colorado- Nutrition Obesity Research Center

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phentermine & Topiramate	Experimental	Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning + Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning + Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)	Drug: Phentermine Drug: Immediate Release Topiramate
Placebo Drugs	Placebo Comparator	Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning + Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning + Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits)	Drug: Placebo for Phentermine Drug: Placebo for Immediate Release Topiramate

Name	Type	Description	Arm Group Labels	Other Names
Phentermine	Drug	Phentermine tablet	Phentermine & Topiramate	Lomaira

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enrollment Rate	(Number enrolled divided by number eligible) x 100	6 months
Dropout Rate	Number who do not complete the study divided by number enrolled	24 months
Number of Participants Adherent to Study Drugs	Presence of amphetamine in the urine at any study visit	12 weeks
Frequency of Adverse Events	Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Percent BMI Change	(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100	Baseline and 12 weeks
Percent Weight Change	(Baseline weight - weight at 12 weeks)/Baseline weight x 100

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Status post sleeve gastrectomy or roux-en-y gastric bypass
At 6 months after bariatric surgery, has not achieved >= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (>=120% of 95th%ile or BMI >=35kg/m2 for 12-17yo; BMI >=35kg/m2 for 18-24yo)

Exclusion Criteria:

Absolute contraindication to phentermine or topiramate (i.e. phentermine:

history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)

Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
Use of anti-obesity medication within 6 months of screening
Initiation of a new medication associated with weight loss or gain within 30 days of screening
Type 2 diabetes mellitus
Hypothalamic obesity
Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
History of schizophrenia
Severe hepatic impairment (ALT >10x upper limit of normal or known synthetic liver dysfunction)
Moderate or severe renal impairment (GFR <30mL/min/1.73m2)
Dosage change to hypertension, dyslipidemia, depression, or anxiety medication <4 weeks prior to study enrollment
Contraception started <7 days prior to study enrollment
Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control

Name	Affiliation	Role
Jaime M Moore, MD, MPH	University of Colorado School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Colorado		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. Dosing schedule for active medication group: Week 1: 4mg phentermine + 25mg immediate release topiramate Week 2: 8mg phentermine + 50mg immediate release topiramate Week 3: 12mg phentermine + 75mg immediate release topiramate Goal Dose: · Weeks 4-12: 16mg phentermine + 100mg immediate release topiramate Discontinuation (at study Visit 4): Week 13: Discontinue Phentermine + Decrease topiramate to 50mg Week 14: Decrease topiramate to 25mg for 7 days, then discontinue Notes: Participants who do not tolerate goal doses will be maintained at the highest tolerated dose. All topiramate and phentermine doses will be taken once daily in the morning.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 21, 2021

ID	Title	Description
BG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
BG001	Placebo	Participants were randomized to receive placebo tablets (compounded to look like phentermine and topiramate) plus standard post-bariatric care.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0017 BG00213

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Enrollment Rate

(Number enrolled divided by number eligible) x 100

Posted

Number

percentage of participants

6 months

ID	Title	Description
OG000	All Eligible Participants Before Randomization	The enrollment rate was calculated before randomization to active or placebo groups.

Units	Counts
Participants	OG00068

Title

Denominators

Categories

Title	Measurements
	OG00019

Primary

Dropout Rate

Number who do not complete the study divided by number enrolled

Posted

Number

percentage who withdrew among enrolled

24 months

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Primary

Number of Participants Adherent to Study Drugs

Presence of amphetamine in the urine at any study visit

The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Primary

Frequency of Adverse Events

Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.

The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.

Posted

Mean

Full Range

unique adverse events per participant

24 months

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Percent BMI Change

(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100

Posted

Mean

Full Range

percent change

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Percent Weight Change

(Baseline weight - weight at 12 weeks)/Baseline weight x 100

Posted

Mean

Full Range

percent change

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in BMI Percent of the 95th%Ile

(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)

For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was <95th%ile or they were >19 completed years at the time point.

Posted

Mean

Full Range

percentile change

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Heart Rate

(Heart rate at baseline - Heart rate at 12 weeks)

Posted

Mean

Full Range

beats per minute

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Systolic Blood Pressure

Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks

Posted

Mean

Full Range

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Diastolic Blood Pressure

Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks

Posted

Mean

Full Range

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Total Cholesterol (mg/dL)

Total cholesterol at baseline - Total cholesterol at 12 weeks

Posted

Mean

Full Range

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Triglycerides (mg/dL)

Triglycerides at baseline - Triglycerides at 12 weeks

Posted

Mean

Full Range

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in LDL Cholesterol (mg/dL)

LDL at baseline - LDL at 12 weeks

Posted

Mean

Full Range

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in HDL Cholesterol (mg/dL)

HDL at baseline - HDL at 12 weeks

Posted

Mean

Full Range

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Alanine Aminotransferase (ALT) (U/L)

ALT at baseline - ALT at 12 weeks

Posted

Mean

Full Range

U/L

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Hemoglobin A1c (HbA1c) (%)

HbA1c at baseline - HbA1c at 12 weeks

Posted

Mean

Full Range

Percentage of glycated hemoglobin

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in % Fat Mass

% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA

Posted

Mean

Full Range

percentage of fat mass

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Resting Metabolic Rate (RMR)

RMR at baseline - RMR at 12 weeks measured by indirect calorimetry

Posted

Mean

Full Range

kilocalories per day

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Daily Kilocalorie Intake

The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.

Posted

Mean

Full Range

kilocalories

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Hunger

The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.

VAS hunger ratings were missing from 1 participant in each the active and placebo groups

Posted

Mean

Full Range

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Satiety

The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.

VAS missing from 1 participant each in the active and placebo groups

Posted

Mean

Full Range

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Eating in the Absence of Hunger

Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.

Each item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.

Total scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.

The mean change in total scores by group are presented.

Posted

Mean

Full Range

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Cognitive Restraint

The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.

The cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.

MINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)

Posted

Mean

Full Range

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants

Secondary

Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report

"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age <=19.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

Posted

Mean

Full Range

units on a transformed scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult

"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

Posted

Mean

Full Range

units on a transformed scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report

PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.

Items are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.

Scale Scores are calculated as the sum of the items over the number of items answered.

Higher scores indicated better health-related quality of life.

Posted

Mean

Full Range

units on a transformed scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants

Secondary

Change in Depression

The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).

Each item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.

Posted

Mean

Full Range

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Secondary

Participant Satisfaction: Questionnaire

The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.

The outcome presented here is the average of the parent and adolescent/young adult dyad's response to the statement: "My overall experience was positive" [1=Strongly disagree, 5=Strongly agree]

Posted

Mean

Full Range

units on a scale

At 12 weeks

ID	Title	Description
OG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.
OG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Restlessness	General disorders	Systematic Assessment		EG0006 affected6 at risk EG0012 affected6 at risk
Depressed mood	Psychiatric disorders	Systematic Assessment	subjectively reported as different from baseline	EG0004 affected6 at risk EG0013 affected6 at risk
Difficulty with sleep	General disorders	Systematic Assessment		EG0004 affected6 at risk EG0013 affected6 at risk
Fatigue	General disorders	Systematic Assessment		EG0005 affected6 at risk EG0012 affected6 at risk
Irritability	Psychiatric disorders	Systematic Assessment		EG0006 affected6 at risk EG0011 affected6 at risk
Paresthesias	Nervous system disorders	Systematic Assessment		EG0006 affected6 at risk EG0011 affected6 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	subjectively reported - above baseline	EG0005 affected6 at risk EG0011 affected6 at risk
Difficulty with concentration/attention	Nervous system disorders	Systematic Assessment		EG0005 affected6 at risk EG0011 affected6 at risk
Nausea/Vomiting	Gastrointestinal disorders	Systematic Assessment		EG0004 affected6 at risk EG0012 affected6 at risk
Change in Taste	Gastrointestinal disorders	Systematic Assessment		EG0003 affected6 at risk EG0012 affected6 at risk
Eye discomfort	Eye disorders	Systematic Assessment		EG0001 affected6 at risk EG0014 affected6 at risk
Flushing	General disorders	Systematic Assessment		EG0004 affected6 at risk EG0011 affected6 at risk
Memory problems	Nervous system disorders	Systematic Assessment		EG0004 affected6 at risk EG0011 affected6 at risk
Menstruation change	Reproductive system and breast disorders	Systematic Assessment	Among participants with biological sex of female	EG0002 affected6 at risk EG0013 affected4 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment		EG0004 affected6 at risk EG0010 affected6 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment		EG0003 affected6 at risk EG0011 affected6 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment		EG0001 affected6 at risk EG0013 affected6 at risk
Mental fogginess	Nervous system disorders	Systematic Assessment		EG0004 affected6 at risk EG0010 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0003 affected6 at risk EG0011 affected6 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0002 affected6 at risk EG0012 affected6 at risk
Word finding difficulties	Nervous system disorders	Systematic Assessment		EG0003 affected6 at risk EG0011 affected6 at risk
Back, side, and/or groin pain	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0003 affected6 at risk EG0010 affected6 at risk
COVID disease	Infections and infestations	Systematic Assessment		EG0001 affected6 at risk EG0012 affected6 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment		EG0001 affected6 at risk EG0012 affected6 at risk
Fever	Infections and infestations	Systematic Assessment		EG0002 affected6 at risk EG0011 affected6 at risk
Blurry vision	Eye disorders	Systematic Assessment		EG0001 affected6 at risk EG0011 affected6 at risk
Decreased sweating	General disorders	Systematic Assessment		EG0001 affected6 at risk EG0011 affected6 at risk
Headache	Nervous system disorders	Systematic Assessment		EG0001 affected6 at risk EG0011 affected6 at risk
Myalgias	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 affected6 at risk EG0012 affected6 at risk
Palpitations	Cardiac disorders	Systematic Assessment		EG0002 affected6 at risk EG0010 affected6 at risk
Esophageal fullness	Gastrointestinal disorders	Systematic Assessment		EG0001 affected6 at risk EG0010 affected6 at risk
Finger fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 affected6 at risk EG0011 affected6 at risk
Inability to cool down	General disorders	Systematic Assessment		EG0001 affected6 at risk EG0010 affected6 at risk
Swelling in arms, legs, face	General disorders	Systematic Assessment		EG0001 affected6 at risk EG0010 affected6 at risk
Syncope	Nervous system disorders	Systematic Assessment		EG0000 affected6 at risk EG0011 affected6 at risk
Vaginal pain	Reproductive system and breast disorders	Systematic Assessment	Among female participants (mentioned under "any other adverse event experienced")	EG0001 affected6 at risk EG0010 affected4 at risk
Depression Score by CES-D that increased from normal to elevated (>=20) on study	Psychiatric disorders	Systematic Assessment		EG0003 affected6 at risk EG0012 affected6 at risk
Suicidality screen (CSSRS) positivity on study	Psychiatric disorders	Systematic Assessment		EG0000 affected6 at risk EG0010 affected6 at risk
Low bicarbonate (<20mmol/L)	Metabolism and nutrition disorders	Systematic Assessment		EG0003 affected6 at risk EG0010 affected6 at risk
Low potassium (<3.5mmol/L)	Metabolism and nutrition disorders	Systematic Assessment		EG0001 affected6 at risk EG0010 affected6 at risk
Elevated creatinine	Renal and urinary disorders	Systematic Assessment	above upper limit of normal mg/dL	EG0001 affected6 at risk EG0010 affected6 at risk
Positive urine pregnancy test	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	Among female participants	EG0000 affected6 at risk EG0010 affected4 at risk
Elevated systolic blood pressure (>=120mmHg)	Cardiac disorders	Systematic Assessment	at any visit while on study treatment	EG0003 affected6 at risk EG0012 affected6 at risk
Elevated diastolic BP (>=80mmHg)	Cardiac disorders	Systematic Assessment	at any visit while on study treatment	EG0001 affected6 at risk EG0013 affected6 at risk
Elevated heart rate (>=100 beats per minute)	Cardiac disorders	Systematic Assessment	at any visit while on study treatment	EG0000 affected6 at risk EG0010 affected6 at risk
Elevated temperature (measured)	General disorders	Systematic Assessment		EG0000 affected6 at risk EG0010 affected6 at risk

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D007661	Ketoses

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phentermine & Topiramate	Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.	0	6	1	6	6	6
EG001	Placebo	Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.	0	6	0	6	6	6