Evaluation of Galcanezumab in the Prevention of Chronic M... | NCT02614261

ID	Type	Description	Link
I5Q-MC-CGAI	Other Identifier	Eli Lillly and Company
2015-001883-21	EudraCT Number

Status Module

Oversight 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
Placebo	Placebo Comparator	Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.	Drug: Galcanezumab Drug: Placebo
Galcanezumab 120 mg	Experimental	Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.	Drug: Galcanezumab
Galcanezumab 240 mg	Experimental	Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.

Name	Type	Description	Arm Group Labels	Other Names
Galcanezumab	Drug	Administered SC	Galcanezumab 120 mg Galcanezumab 240 mg Israel Addendum Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)	MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.	Baseline, Month 1 through Month 3

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days	MHD: A calendar day on which a migraine headache or probable migraine headache occurred.	Baseline, Month 1 through Month 3
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain

Eligibility Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
21st Century Neurology		Phoenix	Arizona	85004	United States
Arizona Research Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39901101	Derived	Diener HC, Day KA, Lipsius S, Aurora SK, Hindiyeh NA, Detke HC. Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab. J Headache Pain. 2025 Feb 3;26(1):26. doi: 10.1186/s10194-025-01956-x.
35392739	Derived	Pozo-Rosich P, Detke HC, Wang S, Dolezil D, Li LQ, Aurora SK, Reuter U. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 May;38(5):731-742. doi: 10.1080/03007995.2022.2059975. Epub 2022 Apr 15.

Label	URL
A Study of LY2951742 in the Prevention of Chronic Migraine (REGAIN)	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 22, 2016	Oct 2, 2018

Arm/Group Information

ID	Title	Description
BG000	Placebo	Double-blind treatment phase: Participants received placebo once a month by subcutaneous injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
BG001	Galcanezumab 120mg	Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
BG002	Galcanezumab 240mg	Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
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
	ParticipantsBG000559 ParticipantsBG001279 ParticipantsBG002279 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000559 ParticipantsBG001279 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000559 ParticipantsBG001279 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000559 ParticipantsBG001279 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
Argentina	ParticipantsBG000559 ParticipantsBG001279 ParticipantsBG002

Migraine Headache Days (MHD)

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

All randomized participants who received at least one dose of study drug.

Mean

Standard Deviation

Days per Month

Title	Denominators	Categories
	ParticipantsBG000558 ParticipantsBG001278 ParticipantsBG002

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

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

Posted

Least Squares Mean

Standard Error

Migraine Headache Days per Month

Baseline, Month 1 through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.

Units	Counts
Participants	OG000538 OG001273 OG002274

Title

Denominators

Categories

Title	Measurements
	OG000-2.74± 0.36 OG001-4.83± 0.44 OG002-4.62± 0.43

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		Mixed Models Analysis		<.001		LSMean Difference	-2.09	Standard Error of the Mean	0.42	2-Sided	95	-2.92	-1.26					Superiority
OG000 OG002		Mixed Models Analysis		<.001

Secondary

Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.

Posted

Count of Participants

Participants

Baseline, Month 1 through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg of galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.

Units	Counts
Participants

Secondary

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain

MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.

LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.

Secondary

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.

Posted

Least Squares Mean

Standard Error

Days Per Month

Baseline, Month 1 through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Secondary

Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score

PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Secondary

Overall Mean Change From Baseline in Headache Hours

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline measurement.

Posted

Least Squares Mean

Standard Error

Headache Hours per Month

Baseline, Month 1 through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240 mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Secondary

Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score

The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.

Secondary

Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab

A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.

All randomized participants who received at least one dose of study drug and had at least one non-missing test result for ADA for each of the baseline period and the post baseline period.

Posted

Count of Participants

Participants

Month 1 through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Secondary

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.

Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.

Posted

Baseline through Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Units	Counts
Participants

Secondary

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

All randomized participants who received at least one dose of study drug and had measurable plasma concentrations.

Posted

Mean

Standard Deviation

Nanogram per milliliter (ng/mL)

Month 3

ID	Title	Description
OG000	Placebo	Participants received placebo once a month by subcutaneous injection for 3 months.
OG001	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month by subcutaneous injection for 2 months.
OG002	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Units	Counts
Participants

Secondary

Serum Concentrations of Galcanezumab

Serum concentrations of Galcanezumab

All randomized participants who received at least one dose of Galcanezumab and had measurable serum concentrations.

Posted

Mean

Standard Deviation

Nanogram per milliliter (ng/mL)

Month 3

ID	Title	Description
OG000	Galcanezumab 120mg	Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
OG001	Galcanezumab 240mg	Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo - Double-Blind Treatment Phase	Participants received placebo once a month by subcutaneous injection for 3 months.	558	5	558	170	558
EG001	Galcanezumab 120mg - Double-Blind Treatment Phase	Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.	273	2	273	98	273
EG002	Galcanezumab 240mg - Double-Blind Treatment Phase	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.	282	4	282	105	282
EG003	Placebo/Galcanezumab - Open-Label Extension Phase	After completion of Placebo double-blind phase, participants had an option to enter open-label extension phase where they received 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.	501	16	501	223	501
EG004	Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase	After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.	259	6	259	117	259
EG005	Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase	After completion of Galcanezumab 240mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.	262	9	262	120	262
EG006	Placebo - Follow-up Phase	Participants entered follow-up phase from placebo double-blind treatment phase and were observed for 4 months. No treatments administered.	15	0	15	0	15
EG007	Galcanezumab 120mg - Follow-up Phase	Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.	4	0	4	0	4
EG008	Galcanezumab 240mg - Follow-up Phase	Participants entered follow-up phase from from Galcanezumab 240mg double-blind treatment phase and were observed for 4 months. No treatments administered.	4	0	4	2	4
EG009	Placebo/Galcanezumab - Follow-up Phase	Participants entered follow-up phase from Placebo/Galcanezumabopen-label extension phase and were observed for 4 months. No treatments administered.	438	5	438	57	438
EG010	Galcanezumab 120mg/Galcanezumab - Follow-up Phase	Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.	223	3	223	19	223
EG011	Galcanezumab 240mg/Galcanezumab - Follow-up Phase	Participants entered follow-up phase from Galcanezumab 240mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.	228	1	228	27	228
EG012	Israel Addendum	Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.	29	6	29	26	29

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG0031 events1 affected501 at risk EG004
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Congenital diaphragmatic hernia	Congenital, familial and genetic disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Swelling face	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Chronic tonsillitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Complicated appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0011 events1 affected273 at risk EG0020 events0 affected282 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Malignant nipple neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0011 events1 affected273 at risk EG0020 events0 affected282 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected483 at risk EG0010 events0 affected232 at risk EG0020 events0 affected231 at risk EG003
Migraine	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Seizure	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected483 at risk EG0010 events0 affected232 at risk EG0020 events0 affected231 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Varicose vein	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG0030 events0 affected501 at risk EG0040 events0 affected259 at risk EG0050 events0 affected262 at risk EG0060 events0 affected15 at risk EG0070 events0 affected4 at risk EG0081 events1 affected4 at risk EG0090 events0 affected438 at risk EG0100 events0 affected223 at risk EG0110 events0 affected228 at risk EG0120 events0 affected29 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0011 events1 affected273 at risk EG0022 events2 affected282 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00026 events22 affected558 at risk EG00112 events9 affected273 at risk EG0028 events8 affected282 at risk EG003
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0012 events2 affected273 at risk EG0022 events1 affected282 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected558 at risk EG0016 events6 affected273 at risk EG0028 events7 affected282 at risk EG003
Influenza like illness	General disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected558 at risk EG0014 events4 affected273 at risk EG0024 events4 affected282 at risk EG003
Injection site erythema	General disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected558 at risk EG0015 events4 affected273 at risk EG00216 events13 affected282 at risk EG003
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG00032 events24 affected558 at risk EG00131 events18 affected273 at risk EG00233 events21 affected282 at risk EG003
Injection site reaction	General disorders	MedDRA 24.0	Systematic Assessment	EG00016 events10 affected558 at risk EG00113 events8 affected273 at risk EG00219 events15 affected282 at risk EG003
Peripheral swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0011 events1 affected273 at risk EG0021 events1 affected282 at risk EG003
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0015 events5 affected273 at risk EG0021 events1 affected282 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected558 at risk EG0015 events5 affected273 at risk EG0021 events1 affected282 at risk EG003
Covid-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0012 events2 affected273 at risk EG0022 events2 affected282 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00016 events15 affected558 at risk EG0010 events0 affected273 at risk EG0026 events6 affected282 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00026 events24 affected558 at risk EG00120 events18 affected273 at risk EG0029 events9 affected282 at risk EG003
Pancreas infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0011 events1 affected273 at risk EG0022 events2 affected282 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected558 at risk EG0014 events4 affected273 at risk EG0027 events7 affected282 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00014 events14 affected558 at risk EG00110 events8 affected273 at risk EG0029 events9 affected282 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected558 at risk EG0016 events6 affected273 at risk EG0025 events5 affected282 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0008 events8 affected558 at risk EG0012 events2 affected273 at risk EG0025 events5 affected282 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00015 events14 affected558 at risk EG0019 events8 affected273 at risk EG0022 events2 affected282 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected558 at risk EG0018 events7 affected273 at risk EG0020 events0 affected282 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected558 at risk EG0013 events3 affected273 at risk EG0022 events2 affected282 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00020 events19 affected558 at risk EG0017 events6 affected273 at risk EG00210 events9 affected282 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected558 at risk EG0014 events4 affected273 at risk EG0021 events1 affected282 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Tremor	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected558 at risk EG0011 events1 affected273 at risk EG0020 events0 affected282 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected558 at risk EG0014 events4 affected273 at risk EG0024 events4 affected282 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected558 at risk EG0012 events2 affected273 at risk EG0024 events4 affected282 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected558 at risk EG0010 events0 affected273 at risk EG0020 events0 affected282 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected558 at risk EG0010 events0 affected273 at risk EG0021 events1 affected282 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected558 at risk EG0013 events2 affected273 at risk EG0020 events0 affected282 at risk EG003

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms