Opioid Prescription After Cesarean Trial | NCT04296396

Secondary IDs

ID	Type	Link
U24HD036801	U.S. NIH Grant/Contract	View source
UG1HD087230	U.S. NIH Grant/Contract	View source
UG1HD027869	U.S. NIH Grant/Contract	View source
UG1HD027915	U.S. NIH Grant/Contract	View source
UG1HD034208	U.S. NIH Grant/Contract	View source
UG1HD040500	U.S. NIH Grant/Contract	View source
UG1HD040485	U.S. NIH Grant/Contract	View source
UG1HD053097	U.S. NIH Grant/Contract	View source
UG1HD040544	U.S. NIH Grant/Contract	View source
UG1HD040545	U.S. NIH Grant/Contract	View source
UG1HD040560	U.S. NIH Grant/Contract	View source
UG1HD040512	U.S. NIH Grant/Contract	View source
UG1HD087192	U.S. NIH Grant/Contract	View source

Status Module

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individualized Opioid Prescription	Experimental	Individualized opioid prescription protocol and shared decision making	Drug: 0 to 20 tablets of oxycodone 5mg
Fixed Opioid Prescription	Other	Fixed opioid prescription of 20 tablets of oxycodone 5mg	Drug: Fixed opioid prescription

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0 to 20 tablets of oxycodone 5mg	Drug	Individualized opioid prescription protocol (IOPP) that includes shared decision making	Individualized Opioid Prescription

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory	Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.	1 week post hospital discharge

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge	Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum	After hospital discharge and up to 90 days postpartum

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Monica Longo, MD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham		Birmingham	Alabama	35233	United States
Northwestern University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38857509	Derived	Smid MC, Clifton RG, Rood K, Srinivas S, Simhan HN, Casey BM, Longo M, Landau R, MacPherson C, Bartholomew A, Sowles A, Reddy UM, Rouse DJ, Bailit JL, Thorp JM Jr, Chauhan SP, Saade GR, Grobman WA, Macones GA; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Aug 1;144(2):195-205. doi: 10.1097/AOG.0000000000005649. Epub 2024 Jun 10.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

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	Jun 1, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Individualized Opioid Prescription	Individualized opioid prescription protocol (IOPP) with shared decision making IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
BG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0002748 BG0012772 BG0025520

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Data is missing for one participant in each group.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001497 OG0011535

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	0.67			2-Sided	95	-2.03	3.37			The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).		Non-Inferiority	A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).

Secondary

Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge

Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum

Of 2273 participants in the fixed group, 1 was enrolled in the study for a second pregnancy. Only the first pregnancy was included in the analysis. This data was missing for 94 participants in the individualized opioid prescription group and 76 participants in the fixed group.

Posted

Count of Participants

Participants

After hospital discharge and up to 90 days postpartum

ID	Title	Description
OG000	Individualized Opioid Prescription	Individualized opioid prescription protocol and shared decision making 0 to 20 tablets of oxycodone 5mg: Individualized opioid prescription protocol (IOPP) that includes shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	fixed opioid prescription of 20 tablets of oxycodone 5mg

Units	Counts

Secondary

Number of Opioid Prescriptions Filled

Number of opioid prescriptions filled by ninety days postpartum

94 missing in the IOPP group. 75 missing in the fixed group

Posted

Count of Participants

Participants

90 days postpartum

ID	Title	Description
OG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants	OG000

Secondary

Number of Opioid Tablets Unused Since Discharge

Number of opioid tablets unused from discharge to 90 days postpartum

Data were missing for 207 participants in the IOPP group and for 180 in the fixed group.

Posted

Median

Inter-Quartile Range

tablets

90 days postpartum

ID	Title	Description
OG000	Individualized Opioid Prescription	Individualized opioid prescription protocol (IOPP) with shared decision making IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants	OG000

Secondary

Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge

Total morphine milligram equivalents (MME) used from discharge to 2 weeks post-discharge. MME is the amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength.

Posted

Median

Inter-Quartile Range

morphine milligram equivalent

2 weeks post discharge

ID	Title	Description
OG000	Individualized Opioid Prescription	Individualized opioid prescription protocol (IOPP) with shared decision making IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants	OG000

Secondary

Worst Pain Severity Score at 2 Weeks Post Discharge

Pain severity scores assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.

Data were missing for 234 participants in the IOPP group and for 286 in the fixed group

Posted

Median

Inter-Quartile Range

score on a scale

2 weeks post discharge

ID	Title	Description
OG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants	OG000

Secondary

Pain Interference Score ≥ 4 at 2 Weeks Post Discharge

Pain interference scores ≥ 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory.

Data were missing for 234 participants in the IOPP group and for 286 in the fixed group

Posted

Count of Participants

Participants

2 weeks post discharge

ID	Title	Description
OG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants

Secondary

Number of Participants Who Indicated an Improved Global Impression of Change

Number of participants who indicated an improved global impression of change in overall pain at 2 weeks post-discharge. This represents a selection on a multiple choice survey question with the response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

Posted

Count of Participants

Participants

2 weeks post discharge

ID	Title	Description
OG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants	OG000

Secondary

Infant Hospital Readmissions

Proportion of infants readmitted to the hospital

2856 and 2889. Data is missing for 102 neonates in the IOPP group and 92 neonates in the fixed opioid group.

Posted

Count of Participants

Participants

6 weeks postpartum

ID	Title	Description
OG000	Individualized Opioid Prescription (IOPP) -Neonates/Infants	Neonates/infants of participants in the Individualized opioid prescription protocol (IOPP) with shared decision making group.
OG001	Fixed Opioid Prescription - Neonates/Infants	Neonates/infants of participants in the fixed opioid prescription group.

Units	Counts
Participants	OG000

Secondary

Maternal Depression Score ≥ 13

The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week.

data is missing for 252 participants in the IOPP group and 276 participants in the fixed prescription group

Posted

Count of Participants

Participants

6 weeks postpartum

ID	Title	Description
OG000	Individualized Opioid Prescription Protocol (IOPP)	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.
OG001	Fixed Opioid Prescription	Fixed amount of opioids (20 tablets of oxycodone 5mg)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Individualized Opioid Prescription (IOPP) -Mother	Individualized opioid prescription protocol (IOPP) with shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean.	0	2,748	133	2,748	166	2,748
EG001	Fixed Opioid Prescription -Mother	Fixed amount of opioids (20 tablets of oxycodone 5mg)	0	2,772	96	2,772	186	2,772
EG002	Individualized Opioid Prescription (IOPP) -Neonates/Infants	Neonates/infants of participants in the Individualized opioid prescription protocol (IOPP) with shared decision making group.	11	2,856	37	2,856	0	2,856
EG003	Fixed Opioid Prescription - Neonates/Infants	Neonates/infants of participants in the fixed opioid prescription group.	8	2,889	30	2,889	0	2,889

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Bradycardia	Cardiac disorders	Non-systematic Assessment	includes cardiac arrest and coarctation of aorta	EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG0030 events0 affected2,889 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Angiodysplasia of duodenum	Gastrointestinal disorders	Non-systematic Assessment		EG0002 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Abdominal pain	General disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Fever	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0022 events2 affected2,856 at risk EG003
Neonatal death	General disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG00210 events10 affected2,856 at risk EG003
Polydactyly	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Mastitis	Reproductive system and breast disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Abdominal adhesions	Reproductive system and breast disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Heavy vaginal bleeding	Reproductive system and breast disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Intra-abdominal fluid collection	Reproductive system and breast disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Postpartum endometritis	Reproductive system and breast disorders	Non-systematic Assessment		EG0008 events8 affected2,748 at risk EG0019 events9 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Septic pelvic thrombophlebitis	Reproductive system and breast disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Chest Pain	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Fluid overload	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0012 events2 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Myocardial infarction type 2	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
New onset diastolic heart failure	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Intraparenchymal hemorrhage	Blood and lymphatic system disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Lower extremity swelling	Blood and lymphatic system disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Venous thromboembolism	Blood and lymphatic system disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Appendicitis	Gastrointestinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Cholecystectomy	Gastrointestinal disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Cholecystitis	Gastrointestinal disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Cholelithiasis	Gastrointestinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Ileus	Gastrointestinal disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0012 events2 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Bowel obstruction	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Distal bowel stricture	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Gastroesophageal reflux	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Intrauterine bowel perforation	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Meconium pseudocyst and volvulous	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Poor feeding	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0022 events2 affected2,856 at risk EG003
Sepsis	Blood and lymphatic system disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Poor weight gain	General disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Pale/Stiff	General disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Suspected congenital adrenal hyperplasia	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Trisomy 18	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Cardiac arrest	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Coarctation of aorta	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Hyperbilirubinemia	Blood and lymphatic system disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0026 events6 affected2,856 at risk EG003
Hypospadias	Reproductive system and breast disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Encephalomalacia	Nervous system disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Hydrocephalus	Nervous system disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Seizures	Nervous system disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Glioblastoma	Nervous system disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Postpartum preeclampsia	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG00063 events62 affected2,748 at risk EG00156 events54 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Bipolar disorder	Psychiatric disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Depression	Psychiatric disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Major depressive disorder	Psychiatric disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Panic disorder	Psychiatric disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Pyelonephritis	Renal and urinary disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Urinary tract infection	Renal and urinary disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Urinary retention	Renal and urinary disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
COVID-19	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0012 events2 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0002 events2 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Respiratory infection	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0025 events4 affected2,856 at risk EG003
Escherichia coli cystitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0021 events1 affected2,856 at risk EG003
Abscess	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0006 events6 affected2,748 at risk EG0015 events5 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Cellulitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0001 events1 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Incisional bleeding	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Wound infection	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG00025 events23 affected2,748 at risk EG00111 events10 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003
Hypothermia	Vascular disorders	Non-systematic Assessment		EG0000 events0 affected2,748 at risk EG0010 events0 affected2,772 at risk EG0023 events3 affected2,856 at risk EG003
Choledocholithiasis	Gastrointestinal disorders	Non-systematic Assessment		EG0002 events1 affected2,748 at risk EG0011 events1 affected2,772 at risk EG0020 events0 affected2,856 at risk EG003

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms