A Phase III Study to Test the Benefit of a New Kind of An... | NCT00796445

ID	Type	Description	Link
2008-002447-16	EudraCT Number

Label	Type	Description	Intervention Names
MAGE-A3 Group	Experimental	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.	Drug: GSK 2132231A
Placebo Group	Placebo Comparator	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GSK 2132231A	Drug	IM solution, a course of 13 injections administered over 27 months	MAGE-A3 Group

Measure	Description	Time Frame
Disease Free Survival (DFS)	DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).	At Final analysis (Month 30 = Year 2.5)
Disease Free Survival (DFS)	DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).	At follow-up analysis (up to Year 5)

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.	At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35243	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
29908991	Background	Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.
31732522

Label	URL
IPD for this study will be made available via the Clinical Study Data Request site.	View source

ID	Title	Description
FG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

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

Disease Free Survival (DFS)

DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).

The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.

Posted

Number

First events per person-year

At Final analysis (Month 30 = Year 2.5)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
OG002	GS+ Mage-A3 Sub-Group	Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG003	GS+ Placebo Sub-Group	Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
OG004	GS- Mage-A3 Sub-Group	Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Units	Counts
Participants	OG000893 OG001452 OG002200 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.505 OG0010.478 OG0020.500 OG003

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	At Final analysis (Month 30)	Regression, Cox		0.8566		Hazard Ratio (HR)	1.013			2-Sided	95	0.879	1.169					Non-Inferiority	The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.

Primary

Disease Free Survival (DFS)

The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.

Posted

Number

First events per person-year

At follow-up analysis (up to Year 5)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Secondary

Overall Survival (OS)

Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.

Posted

Number

Events per person-year

At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Disease-free Specific Survival (DFSS)

Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).

The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.

Posted

Number

First events per person-year

At Final analysis (Month 30 = Year 2.5)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Distant Metastasis-free Survival (DMFS)

Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).

The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.

Posted

Number

First events per person-year

At Final analysis (Month 30 = Year 2.5)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Health-related Quality of Life

The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.

The analysis was performed on subjects with valid EQ-5D data from the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.

Posted

Mean

Standard Deviation

Units on a scale

At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Secondary

Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value

The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.

Posted

Count of Participants

Participants

At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Anti-MAGE-A3 Antibody Geometric Mean Concentrations

Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Number of Subjects With Anti-MAGE-A3 Antibody Response

Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration.

Posted

Count of Participants

Participants

At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Number of Subjects With Abnormal Haematological and Biochemical Parameters

Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.

The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.

Posted

Count of Participants

Participants

Within the 31-day (Days 0-30) post-treatment period

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Number of Subjects With Any Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.

Posted

Count of Participants

Participants

Within the 31-day (Days 0-30) follow-up period after treatment

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.

Posted

Count of Participants

Participants

From Day 0 up to study end (up to 5 years)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Secondary

Number of Subjects With Potential Immune-mediated Diseases (pIMDs)

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.

Posted

Count of Participants

Participants

From Day 0 up to study end (up to 5 years)

ID	Title	Description
OG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
OG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Atrioventricular block	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Left ventricular failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Basedow's disease	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymphocytic hypophysitis	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Polyglandular autoimmune syndrome type ii	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Retinal detachment	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Retinal vascular thrombosis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Retinopathy	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Device dislocation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Impaired healing	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0012 events2 affected450 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Jaundice	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Sarcoidosis	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Abscess limb	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Appendicitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0015 events5 affected450 at risk
Cellulitis enterococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Cystitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0009 events7 affected895 at risk EG0015 events5 affected450 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
H1n1 influenza	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Localised infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymph node abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymphangitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0011 events1 affected450 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Pilonidal cyst	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Post procedural infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Postoperative abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Prostatitis escherichia coli	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Streptococcal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Urosepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Wound infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Transaminases increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0011 events1 affected450 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0011 events1 affected450 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG00034 events25 affected895 at risk EG00114 events13 affected450 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Focal nodular hyperplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0009 events9 affected895 at risk EG0013 events3 affected450 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Malignant melanoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Porocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0009 events6 affected895 at risk EG0013 events3 affected450 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Meningism	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Polyneuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Psychomotor skills impaired	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Major depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Mental disorder	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Mental status changes	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0012 events1 affected450 at risk
Bladder neck sclerosis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected895 at risk EG0010 events0 affected450 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected895 at risk EG0010 events0 affected450 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0010 events0 affected450 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Actinic elastosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Aortic aneurysm	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected895 at risk EG0011 events1 affected450 at risk
Haematoma	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0011 events1 affected450 at risk
Intermittent claudication	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Lymphocele	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk
Lymphoedema	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected895 at risk EG0010 events0 affected450 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected895 at risk EG0010 events0 affected450 at risk
Thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected895 at risk EG0011 events1 affected450 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCIStudy products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
BG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MAGE-A3 Group	Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.	5	895	129	895	819	895
EG001	Placebo Group	Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.	1	450	64	450	327	450

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00061 events46 affected895 at risk EG00126 events19 affected450 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG000266 events123 affected895 at risk EG00143 events32 affected450 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG000354 events149 affected895 at risk EG00168 events46 affected450 at risk
Chills	General disorders	MedDRA 18.1	Systematic Assessment	EG000432 events179 affected895 at risk EG00123 events15 affected450 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG000490 events210 affected895 at risk EG001116 events63 affected450 at risk
Influenza like illness	General disorders	MedDRA 18.1	Systematic Assessment	EG000902 events261 affected895 at risk EG00146 events30 affected450 at risk
Injection site erythema	General disorders	MedDRA 18.1	Systematic Assessment	EG000241 events90 affected895 at risk EG0013 events3 affected450 at risk
Injection site oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG000134 events48 affected895 at risk EG0015 events3 affected450 at risk
Injection site pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0001,057 events325 affected895 at risk EG00137 events22 affected450 at risk
Injection site reaction	General disorders	MedDRA 18.1	Systematic Assessment	EG000500 events160 affected895 at risk EG0019 events6 affected450 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG000480 events191 affected895 at risk EG00126 events19 affected450 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001,240 events380 affected895 at risk EG00144 events35 affected450 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG000165 events84 affected895 at risk EG00143 events31 affected450 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG000456 events188 affected895 at risk EG00139 events23 affected450 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG000207 events115 affected895 at risk EG00128 events26 affected450 at risk
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG000550 events205 affected895 at risk EG001128 events55 affected450 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG000297 events138 affected895 at risk EG00110 events10 affected450 at risk