An Extension Study to Evaluate the Long-Term Safety and T... | NCT02873221

An Extension Study to Evaluate the Long-Term Safety and T... | NCT02873221 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	Active Comparator	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.	Drug: Usual Care
Ubrogepant 50 mg	Experimental	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	Drug: Ubrogepant Drug: Placebo-matching Ubrogepant
Ubrogepant 100 mg	Experimental	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	Drug: Ubrogepant

Name	Type	Description	Arm Group Labels	Other Names
Ubrogepant	Drug	Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.	Ubrogepant 100 mg Ubrogepant 50 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.	56 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Clinically Significant Laboratory Values	Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings

Contacts/Locations Module

Name	Affiliation	Role
Adele Thorpe	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research, Inc.		Birmingham	Alabama	35211	United States
East Family Physicians PC/Radiant Research, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35977836	Derived	Lipton RB, Dodick DW, Goadsby PJ, Burstein R, Adams AM, Lai J, Yu SY, Finnegan M, Kuang AW, Trugman JM. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain. Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17.
34874514	Derived

Label	URL
More Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
FG001	Ubrogepant 50 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 11, 2018	Aug 2, 2019

Type	Comment	Reasons
Other Miscellaneous Reasons		FG0000 subjects FG0012 subjects FG0021 subjects
Non-Compliance with Study Drug		FG0000 subjects FG0013 subjects FG0022 subjects
Protocol Violation		FG0002 subjects FG0015 subjects FG0028 subjects
Pregnancy		FG0004 subjects FG0016 subjects FG0023 subjects
Lack of Qualifying Event		FG0000 subjects FG0013 subjects FG0021 subjects
Withdrawal of Consent		FG00052 subjects FG00151 subjects FG00241 subjects
Lack of Efficacy		FG0000 subjects FG00117 subjects FG00212 subjects
Adverse Event		FG0004 subjects FG0019 subjects FG00211 subjects
Lost to Follow-up		FG00026 subjects FG00130 subjects FG00226 subjects

Safety Follow-up Period

Type	Comment	Milestone Data
STARTED		FG000350 subjects FG001356 subjects FG002364 subjects
COMPLETED		FG000343 subjects FG001339 subjects FG002350 subjects
NOT COMPLETED		FG0007 subjects FG00117 subjects FG00214 subjects

Type	Comment	Reasons
Other Miscellaneous Reasons		FG0000 subjects FG0012 subjects FG0020 subjects
Protocol Violation		FG000

Arm/Group Information

ID	Title	Description
BG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
BG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
BG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
BG003	Total	Total of all reporting groups

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
	BG00041.7± 11.7 BG00142.2± 12.2 BG00241.2± 11.2 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000367 BG001384 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000356 BG001358 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00062 BG00164 BG002

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

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.

The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.

Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.

Posted

Number

Percentage of Participants

56 Weeks

ID	Title	Description
OG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
OG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
OG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Units	Counts
Participants	OG000417 OG001404 OG002409

Title

Denominators

Categories

Title	Measurements
	OG00065 OG00166.3 OG00272.6

Secondary

Number of Participants With Clinically Significant Laboratory Values

Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.

Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm

Posted

Count of Participants

Participants

56 Weeks

ID	Title	Description
OG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
OG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
OG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Secondary

Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings

ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.

Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm

Posted

Count of Participants

Participants

56 Weeks

ID	Title	Description
OG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
OG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
OG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Secondary

Number of Participants With Clinically Significant Vital Sign Measurements

Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.

The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.

Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm

Posted

Count of Participants

Participants

56 Weeks

ID	Title	Description
OG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
OG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
OG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Secondary

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales

On the C-SSRS, the 5 types of suicidal ideation are:

Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.

Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm

Posted

Count of Participants

Participants

56 Weeks

ID	Title	Description
OG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
OG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
OG002	Ubrogepant 100 mg

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Usual Care	Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.	417	17	417	132	417
EG001	Ubrogepant 50 mg	Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	404	9	404	125	404
EG002	Ubrogepant 100 mg	Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	409	12	409	138	409

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0021 affected409 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0011 affected404 at risk EG0021 affected409 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Hemiparesis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Non-cardiac chest pain	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Pneumonia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0011 affected404 at risk EG0021 affected409 at risk
Sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Suicidal ideation	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0021 affected409 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Appendicitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Device allergy	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Diverticulum	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Femoral hernia incarcerated	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Gait disturbance	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Hypertensive crisis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Migraine	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Post procedural infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk
Sinus tachycardia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Substance-induced mood disorder	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected417 at risk EG0011 affected404 at risk EG0020 affected409 at risk
Syncope	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected417 at risk EG0010 affected404 at risk EG0020 affected409 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00033 affected417 at risk EG00133 affected404 at risk EG00247 affected409 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00048 affected417 at risk EG00147 affected404 at risk EG00244 affected409 at risk
Sinusitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00025 affected417 at risk EG00128 affected404 at risk EG00226 affected409 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00023 affected417 at risk EG00122 affected404 at risk EG00226 affected409 at risk
Influenza	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00021 affected417 at risk EG00117 affected404 at risk EG00225 affected409 at risk

Title

Denominators

Categories

Basophils Absolute Cell Count (10**9/L) >2×ULN

- ParticipantsOG000397
- ParticipantsOG001397
- ParticipantsOG002405

Title	Measurements
	OG0000 OG0010 OG0020

Eosinophils Absolute Cell Count (10**9/L) >2×ULN

- ParticipantsOG000397
- ParticipantsOG001397
- ParticipantsOG002405

Title	Measurements
	OG000

Hematocrit (RATIO) <0.9×LLN

- ParticipantsOG000397
- ParticipantsOG001396
- ParticipantsOG002406

Title	Measurements
	OG000

Hematocrit (RATIO) >1.1×ULN

- ParticipantsOG000397
- ParticipantsOG001396
- ParticipantsOG002406

Title	Measurements
	OG000

Hemoglobin (g/L) <0.9×LLN

- ParticipantsOG000395
- ParticipantsOG001395
- ParticipantsOG002405

Title	Measurements
	OG000

Hemoglobin (g/L) >1.1×ULN

- ParticipantsOG000395
- ParticipantsOG001395
- ParticipantsOG002405

Title	Measurements
	OG000

Lymphocytes Absolute Cell Count (10**9/L) <0.7×LLN

- ParticipantsOG000395
- ParticipantsOG001397
- ParticipantsOG002404

Title	Measurements
	OG000

Lymphocytes Absolute Cell Count (10**9/L) >1.3×ULN

- ParticipantsOG000395
- ParticipantsOG001397
- ParticipantsOG002404

Title	Measurements
	OG000

Monocytes Absolute Cell Count (10**9/L) <0.5×LLN

- ParticipantsOG000397
- ParticipantsOG001397
- ParticipantsOG002405

Title	Measurements
	OG000

Monocytes Absolute Cell Count (10**9/L) >2×ULN

- ParticipantsOG000397
- ParticipantsOG001397
- ParticipantsOG002405

Title	Measurements
	OG000

Neutrophils Absolute Cell Count (10**9/L) <0.7×LLN

- ParticipantsOG000396
- ParticipantsOG001395
- ParticipantsOG002401

Title	Measurements
	OG000

Neutrophils Absolute Cell Count (10**9/L) >1.3×ULN

- ParticipantsOG000396
- ParticipantsOG001395
- ParticipantsOG002401

Title	Measurements
	OG000

Platelet Count (Thrombocytes) (10**9/L) <0.5×LLN

- ParticipantsOG000394
- ParticipantsOG001394
- ParticipantsOG002404

Title	Measurements
	OG000

Platelet Count (Thrombocytes) (10**9/L) >1.5×ULN

- ParticipantsOG000394
- ParticipantsOG001394
- ParticipantsOG002404

Title	Measurements
	OG000

Red Blood Cell Count (10**12/L) <0.9×LLN

- ParticipantsOG000395
- ParticipantsOG001398
- ParticipantsOG002401

Title	Measurements
	OG000

Red Blood Cell Count (10**12/L) >1.1×ULN

- ParticipantsOG000395
- ParticipantsOG001398
- ParticipantsOG002401

Title	Measurements
	OG000

White Blood Cell Count (10**9/L) <0.9×LLN

- ParticipantsOG000396
- ParticipantsOG001397
- ParticipantsOG002403

Title	Measurements
	OG000

White Blood Cell Count (10**9/L) >1.5×ULN

- ParticipantsOG000396
- ParticipantsOG001397
- ParticipantsOG002403

Title	Measurements
	OG000

Alanine Aminotransferase (SGPT) (U/L) >3×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Albumin (g/L) <0.8×LLN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Albumin (g/L) >1.2×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Alkaline Phosphatase (U/L) >3×ULN

- ParticipantsOG000396
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Aspartate Aminotransferase (SGOT) (U/L) >3×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Bicarbonate (HCO3) (mmol/L) <0.9×LLN

- ParticipantsOG000386
- ParticipantsOG001392
- ParticipantsOG002395

Title	Measurements
	OG000

Bicarbonate (HCO3) (mmol/L) >1.1×ULN

- ParticipantsOG000386
- ParticipantsOG001392
- ParticipantsOG002395

Title	Measurements
	OG000

Bilirubin, Total (umol/L) >1.5×ULN

- ParticipantsOG000396
- ParticipantsOG001398
- ParticipantsOG002405

Title	Measurements
	OG000

Blood Urea Nitrogen (mmol/L) >1.5×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Calcium (mmol/L) <0.9×LLN

- ParticipantsOG000396
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Calcium (mmol/L) >1.1×ULN

- ParticipantsOG000396
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Chloride (mmol/L) <0.9×LLN

- ParticipantsOG000396
- ParticipantsOG001399
- ParticipantsOG002405

Title	Measurements
	OG000

Chloride (mmol/L) >1.1×UL

- ParticipantsOG000396
- ParticipantsOG001399
- ParticipantsOG002405

Title	Measurements
	OG000

Cholesterol, Total (mmol/L) >1.6×ULN

- ParticipantsOG000397
- ParticipantsOG001397
- ParticipantsOG002405

Title	Measurements
	OG000

Creatine Kinase (U/L) >2×ULN

- ParticipantsOG000392
- ParticipantsOG001395
- ParticipantsOG002398

Title	Measurements
	OG000

Creatinine (umol/L) >1.5×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Glucose, Non-fasting (mmol/L) <0.8×LLN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Glucose, Non-fasting (mmol/L) >2×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Lactate Dehydrogenase (U/L) >3×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Phosphorus (mmol/L) <0.9×LLN

- ParticipantsOG000389
- ParticipantsOG001392
- ParticipantsOG002403

Title	Measurements
	OG000

Phosphorus (mmol/L) >1.1×ULN

- ParticipantsOG000389
- ParticipantsOG001392
- ParticipantsOG002403

Title	Measurements
	OG000

Potassium (mmol/L) <0.9×LLN

- ParticipantsOG000395
- ParticipantsOG001398
- ParticipantsOG002402

Title	Measurements
	OG000

Potassium (mmol/L) >1.1×ULN

- ParticipantsOG000395
- ParticipantsOG001398
- ParticipantsOG002402

Title	Measurements
	OG000

Protein, Total (g/L) <0.9×LLN

- ParticipantsOG000396
- ParticipantsOG001398
- ParticipantsOG002406

Title	Measurements
	OG000

Protein, Total (g/L) >1.1×ULN

- ParticipantsOG000396
- ParticipantsOG001398
- ParticipantsOG002406

Title	Measurements
	OG000

Sodium (mmol/L) <0.9×LLN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Sodium (mmol/L) >1.1×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Triglycerides (mmol/L) >2×ULN

- ParticipantsOG000391
- ParticipantsOG001397
- ParticipantsOG002398

Title	Measurements
	OG000

Uric Acid (Urate) (umol/L) >1.2×ULN

- ParticipantsOG000390
- ParticipantsOG001392
- ParticipantsOG002406

Title	Measurements
	OG000

Glucose Positive

- ParticipantsOG000388
- ParticipantsOG001393
- ParticipantsOG002401

Title	Measurements
	OG000

pH (pH) <0.9×LLN

- ParticipantsOG000397
- ParticipantsOG001398
- ParticipantsOG002406

Title	Measurements
	OG000

pH (pH) >1.1×ULN

- ParticipantsOG000397
- ParticipantsOG001398
- ParticipantsOG002406

Title	Measurements
	OG000

Protein (g/L) Positive

- ParticipantsOG000377
- ParticipantsOG001381
- ParticipantsOG002380

Title	Measurements
	OG000

Specific Gravity >1.1×ULN

- ParticipantsOG000397
- ParticipantsOG001399
- ParticipantsOG002406

Title	Measurements
	OG000

Title

Denominators

Categories

PR interval (msec) PR >= 250

- ParticipantsOG000385
- ParticipantsOG001389
- ParticipantsOG002399

Title	Measurements
	OG0000 OG0010 OG0020

QRS interval (msec) QRS >= 150

- ParticipantsOG000385
- ParticipantsOG001389
- ParticipantsOG002399

Title	Measurements
	OG000

QTc Bazett (msec) QTcB > 500

- ParticipantsOG000385
- ParticipantsOG001388
- ParticipantsOG002399

Title	Measurements
	OG000

QTc Bazett (msec) Increase > 60 (msec)

- ParticipantsOG000385
- ParticipantsOG001388
- ParticipantsOG002399

Title	Measurements
	OG000

QTc Fridericia (msec) QTcF > 500

- ParticipantsOG000385
- ParticipantsOG001388
- ParticipantsOG002399

Title	Measurements
	OG000

QTc Fridericia (msec) Increase > 60 (msec)

- ParticipantsOG000385
- ParticipantsOG001388
- ParticipantsOG002399

Title	Measurements
	OG000

Title

Denominators

Categories

SBP (mmHg) (Sitting) <= 90 and Decrease of >= 20

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG00011 OG00120 OG00212

SBP (mmHg) (Sitting) >= 180 and Increase of >= 20

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

SBP (mmHg) (Standing) <= 90 and Decrease of >= 20

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

SBP (mmHg) (Standing) >= 180 and Increase of >= 20

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

Standing - Sitting SBP (mmHg) <= -20

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

DBP (mmHg) (Sitting) <= 50 and Decrease of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

DBP (mmHg) (Sitting) >= 105 and Increase of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

DBP (mmHg) (Standing) <= 50 and Decrease of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

DBP (mmHg) (Standing) >= 105 and Increase of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

Standing - Sitting DBP (mmHg) <= -15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

PR (beats/min) (Sitting) <= 50, Decrease of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

PR (beats/min) (Sitting) >= 120, Increase of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

PR (beats/min) (Standing) <= 50, Decrease of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

PR (beats/min)(Standing) >= 120, Increase of >= 15

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

Standing - Sitting Pulse Rate (beats/min) >= 25

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

Weight (kg) Decrease of >= 7%

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

Weight (kg) Increase of >= 7%

- ParticipantsOG000398
- ParticipantsOG001400
- ParticipantsOG002406

Title	Measurements
	OG000

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases