Evaluation of Risk Minimization, Assessment and Outcomes... | NCT00640042

Status Module

Oversight Module

Description Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: morphine sulfate extended release capsules

Name	Type	Description	Arm Group Labels	Other Names
morphine sulfate extended release capsules	Drug	30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3	Baseline (Week 0) to Visit 3 (Week 6)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4	Baseline (Week 0) to Visit 4 (Week 10)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study	Baseline (Week 0) to Visit 5 (Week 14 / End of Study)
Number of Subjects With Treatment Emergent Adverse Events	Adverse events that occur or worsen after the first dose of Avinza	Up to 4 months
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)	Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.	Visit 3 (Week 6)

Secondary Outcomes

Measure	Description	Time Frame
Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.	After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.

Eligibility Module

Name	Affiliation	Role
Sherry Siegel, MD	King Pharmaceuticals is now a wholly owned subsidiary of Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Adamsville	Alabama	35005	United States

References Module

Citations

PubMed Identifier	Type	Citation
	Background	The American Pain Foundation. Pain Facts & Figures. January 2007. Available from http://www.painfoundation.org/print.asp?file=Newsroom/PainFacts.htm.
	Background	Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.
11029873	Background	Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1.
11997197

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.7± 13.62

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000839

Male

Title	Measurements
	BG000

Risk level for opioid misuse or abuse

Investigator determined classification of potential risk based on assessment of urine drug tests and patient history and questionnaires

Number

participants

Title

Denominators

Categories

Low

Title	Measurements
	BG000694

Moderate

Title	Measurements
	BG000

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

Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)

Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3

Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)

Posted

Mean

Standard Deviation

units on scale

Baseline (Week 0) to Visit 3 (Week 6)

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000755

Title

Denominators

Categories

Title	Measurements
	OG000-1.6± 2.27

Primary

Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)

Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4

Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)

Posted

Mean

Standard Deviation

units on scale

Baseline (Week 0) to Visit 4 (Week 10)

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000

Primary

Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)

Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study

Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)

Posted

Mean

Standard Deviation

units on scale

Baseline (Week 0) to Visit 5 (Week 14 / End of Study)

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000

Primary

Number of Subjects With Treatment Emergent Adverse Events

Adverse events that occur or worsen after the first dose of Avinza

Posted

Number

participants

Up to 4 months

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000

Primary

Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)

Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.

Number of subjects with risk level assessment at Visit 3 (Week 6)

Posted

Number

participants

Visit 3 (Week 6)

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants

Primary

Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)

Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.

Number of subjects with risk level assessment at Visit 4 (Week 10)

Posted

Number

participants

Visit 4 (Week 10)

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants

Secondary

Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.

After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.

Number of subjects with risk level assessment at Visit 4 (Week 10)

Posted

Number

cases

Up to 4 months

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants

Secondary

Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.

The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.

Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.

Posted

Number

investigators

3 months post study

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000

Secondary

Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.

The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.

Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.

Posted

Number

investigators

6 months post study

ID	Title	Description
OG000	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Units	Counts
Participants	OG000

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	Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.			60	1,487	394	1,487

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected1,487 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected1,487 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Cor pulmonale	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected1,487 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected1,487 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected1,487 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected1,487 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Colitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Accidential death	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Drug withdrawal syndrome	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected1,487 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Diverticulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Heart rate decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Respiratory rate decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected1,487 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected1,487 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Complicated migraine	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hemiparesis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Lethargy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Serotonin syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Agitation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Hallucination	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Restlessness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected1,487 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected1,487 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected1,487 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk
Shock	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected1,487 at risk

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

ID	Term
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