Trial Outcomes & Findings for A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center) (NCT NCT04445792)

NCT ID: NCT04445792

Last Updated: 2025-05-29

Results Overview

Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4284 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2025-05-29

Participant Flow

This record is for the overall master study protocol for the ADOPT PGx trial. The results for the individual trials are reported in separate records.

There were 4284 participants consented into the overall trial. Of the 4284, 174 consented participants were not randomized into the trial and were not assigned to a treatment arm. The remaining 4110 consented participants were randomized and assigned into the treatment arms. The 4110 randomized participants will be described moving forward.

Participant milestones

Measure	Acute Pain, Chronic Pain, and Depression Trial Participants Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm).
Overall Study STARTED	4110
Overall Study COMPLETED	3502
Overall Study NOT COMPLETED	608

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)

Baseline characteristics by cohort

Measure	Acute Pain, Chronic Pain, and Depression Trial Participants n=4110 Participants Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm).
Age, Customized Age, Categorical · <=18 years	264 Participants n=5 Participants
Age, Customized Age, Categorical · 18 to 65 years	2529 Participants n=5 Participants
Age, Customized Age, Categorical · >=65 years	1317 Participants n=5 Participants
Age, Customized Age, Categorical · Unknown or Not Reported	0 Participants n=5 Participants
Sex/Gender, Customized Sex · Female	2827 Participants n=5 Participants
Sex/Gender, Customized Sex · Male	1280 Participants n=5 Participants
Sex/Gender, Customized Sex · Unknown or Not Reported	3 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	2782 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	1276 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender	12 Participants n=5 Participants
Sex/Gender, Customized Gender · Do not identify as female, male, or transgender	28 Participants n=5 Participants
Sex/Gender, Customized Gender · Prefer not to answer	10 Participants n=5 Participants
Sex/Gender, Customized Gender · Unknown	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	381 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3679 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	29 Participants n=5 Participants
Race (NIH/OMB) Asian	71 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	15 Participants n=5 Participants
Race (NIH/OMB) Black or African American	865 Participants n=5 Participants
Race (NIH/OMB) White	2671 Participants n=5 Participants
Race (NIH/OMB) More than one race	99 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	360 Participants n=5 Participants
Region of Enrollment United States	4110 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Individuals who were prescreened.

Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=77 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)	17,496 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 3 years

Population: Individuals who were screened for the Acute Pain, Chronic Pain, and Depression Trials.

Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=17 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials	4,285 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 3 years

Population: Participants who were consented to the Acute Pain, Chronic Pain, and Depression Trials.

Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=4284 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials	4110 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=638 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=627 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=449 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=454 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=556 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	51.0 T-score Standard Deviation 9.4	50.9 T-score Standard Deviation 9.6	62.4 T-score Standard Deviation 8.4	62.2 T-score Standard Deviation 8.6	51.7 T-score Standard Deviation 10.9	51.6 T-score Standard Deviation 11.2

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=642 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=627 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=447 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=455 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=557 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	44.9 T-score Standard Deviation 9.7	45.3 T-score Standard Deviation 9.6	36.0 T-score Standard Deviation 7.5	36.2 T-score Standard Deviation 7.5	47.2 T-score Standard Deviation 9.7	46.8 T-score Standard Deviation 10.3

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=642 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=630 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=448 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=456 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=556 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	48.5 T-score Standard Deviation 9.5	48.5 T-score Standard Deviation 9.5	55.3 T-score Standard Deviation 9.5	54.6 T-score Standard Deviation 9.6	53.8 T-score Standard Deviation 8.9	55.0 T-score Standard Deviation 8.8

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=642 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=630 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=448 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=454 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=557 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	53.4 T-score Standard Deviation 10.3	53.5 T-score Standard Deviation 10.3	44.2 T-score Standard Deviation 9.5	44.9 T-score Standard Deviation 9.8	49.4 T-score Standard Deviation 10.0	48.3 T-score Standard Deviation 10.3

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=640 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=623 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=448 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=456 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=557 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	46.7 T-score Standard Deviation 10.2	46.6 T-score Standard Deviation 10.3	56.0 T-score Standard Deviation 10.8	54.7 T-score Standard Deviation 10.7	55.4 T-score Standard Deviation 9.8	57.0 T-score Standard Deviation 10.7

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=641 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=624 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=449 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=456 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=556 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	45.5 T-score Standard Deviation 9.0	45.2 T-score Standard Deviation 9.0	52.7 T-score Standard Deviation 11.2	51.9 T-score Standard Deviation 11.2	57.5 T-score Standard Deviation 9.3	58.4 T-score Standard Deviation 9.9

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=639 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=626 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=449 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=456 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=557 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	44.0 T-score Standard Deviation 8.2	43.7 T-score Standard Deviation 7.9	51.2 T-score Standard Deviation 10.5	49.7 T-score Standard Deviation 10.6	55.0 T-score Standard Deviation 9.6	56.6 T-score Standard Deviation 9.9

SECONDARY outcome

Timeframe: 6 months

Population: Randomized population with completed 6 month survey.

Overall wellbeing is the sum of the PROMIS 43 subdomain T-scores, with physical function and ability to participate in social roles scores reversed such that higher values within each subscale correspond with poorer health. Overall wellbeing ranges from 259.7 to 541.2, higher scores correspond to worse wellbeing.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=634 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=613 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=444 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=451 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=555 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=556 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	337.4 score on a scale Standard Deviation 51.3	336.2 score on a scale Standard Deviation 51.2	397.6 score on a scale Standard Deviation 50.5	392.1 score on a scale Standard Deviation 50.7	376.8 score on a scale Standard Deviation 51.8	383.6 score on a scale Standard Deviation 53.5

SECONDARY outcome

Timeframe: 10 days for Acute Pain; 3 months for Chronic Pain and Depression

Population: Randomized population with completed 6 month survey.

Concordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications.

Outcome measures

Measure	Individuals Identified as Potential Participants Through EHR n=716 Participants Potential participants for the Acute Pain, Chronic Pain, and Depression Trials.	Acute Pain - Delayed PGx Testing n=699 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Chronic Pain - Immediate PGx Testing n=469 Participants Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider.	Chronic Pain - Delayed PGx Testing n=466 Participants Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period.	Depression - Immediate PGx Testing n=656 Participants Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider.	Depression - Delayed PGx Testing n=656 Participants Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period.
Number of Participants With Pharmacogenetic Drug-Gene Concordance	642 Participants	548 Participants	371 Participants	362 Participants	609 Participants	579 Participants

Adverse Events

Immediate Pharmacogenetics (PGx) Guided Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 5 deaths

Delayed Pharmacogenetics (PGx) Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Immediate Pharmacogenetics (PGx) Guided Therapy n=2550 participants at risk Acute Pain Trial: Immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm). Chronic Pain Trial: Immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm). Depression: Immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm).	Delayed Pharmacogenetics (PGx) Testing n=2550 participants at risk Acute Pain Trial: Standard care and pharmacogenetic testing after 6 months (Control arm). Chronic Pain Trial: Standard care with 6-month delayed pharmacogenetic testing (Control arm). Depression: Standard care with 6-month delayed pharmacogenetic testing (Control arm).
Injury, poisoning and procedural complications Panic Attack due to sample blood draw	0.04% 1/2550 • Approximately 6 months Per the study protocol, only Adverse Device Effect (ADE) events suspected to be related to the specimen collection, laboratory assay genotyping results, and phenoconversion recommendations from the Best Practice Alerts (BPAs)/Consult notes were reported to the IRB. Reportable ADEs or unanticipated Adverse Device Effect (UADEs) events including unanticipated study related deaths will be collected in the study database per IRB reporting policies. Medication side effects were not included as AEs.	0.00% 0/2550 • Approximately 6 months Per the study protocol, only Adverse Device Effect (ADE) events suspected to be related to the specimen collection, laboratory assay genotyping results, and phenoconversion recommendations from the Best Practice Alerts (BPAs)/Consult notes were reported to the IRB. Reportable ADEs or unanticipated Adverse Device Effect (UADEs) events including unanticipated study related deaths will be collected in the study database per IRB reporting policies. Medication side effects were not included as AEs.

Additional Information

Kady-Ann Steen-Burrell, Ph.D.

Duke Clinical Research Institute

Phone: 919-668-8300

Email: kady.ann.steen.burrell@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place