A Study in Ovarian Cancer Patients Evaluating Rucaparib a... | NCT03522246

ID	Type	Description	Link
2017-004557-17	EudraCT Number
2024-516662-11-00	EU Trial (CTIS) Number

Name	Class
Bristol-Myers Squibb	INDUSTRY
Gynecologic Oncology Group	NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER

Label	Type	Description	Intervention Names
Arm A	Experimental	Oral rucaparib + intravenous (IV) nivolumab	Drug: Rucaparib Drug: Nivolumab
Arm B	Experimental	Oral rucaparib + IV placebo	Drug: Rucaparib Drug: Placebo IV Infusion
Arm C	Experimental	Oral placebo + IV nivolumab	Drug: Nivolumab Drug: Placebo Oral Tablet
Arm D	Placebo Comparator	Oral placebo + IV placebo	Drug: Placebo Oral Tablet Drug: Placebo IV Infusion
Japanese Open-label Safety Cohort	Experimental	Oral rucaparib + IV nivolumab	Drug: Rucaparib Drug: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Rucaparib	Drug	Oral rucaparib will be administered twice daily	Arm A Arm B Japanese Open-label Safety Cohort

Measure	Description	Time Frame
Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)	PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: Investigator Assessed PFS	PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: Investigator Assessed PFS	PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Measure	Description	Time Frame
Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS	PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology Associates, PC - HAL		Phoenix	Arizona	85016	United States
Arizona Oncology Associates, PC - HOPE

PubMed Identifier	Type	Citation	Retractions
41115469	Derived	Kristeleit RS, Ghamande S, Lisyanskaya A, Oaknin A, Prendergast E, Kim YB, Fuentes Pradera J, Littell RD, Gao B, Valabrega G, O'Malley DM, Dean A, Pisano C, Buscema J, Provencher D, Zagouri F, Martin LP, Chou HH, Demirkiran F, Ueland F, Chudecka-Glaz A, Yeku O, Beiner M, Anderson C, Drochytek V, Eskander RN, Agarwal R, Maloney L, Despain D, Connor C, Craib M, Shih D, Fujiwara K, Monk BJ. Rucaparib maintenance for newly diagnosed advanced ovarian cancer: interim overall survival, progression-free survival, and safety at 5 years of follow-up from the phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 study. Ann Oncol. 2026 Feb;37(2):217-228. doi: 10.1016/j.annonc.2025.10.007. Epub 2025 Oct 18.
35658487

ID	Title	Description
FG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab intravenous (IV) infusion once every 4 weeks.
FG001	Arm B: Rucaparib + Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 16, 2023	Mar 7, 2025

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

Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)

PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

The homologous recombination deficiency (HRD) population consisted of all randomized participants with either a tumor tissue alteration in breast cancer genes (BRCA)1 or BRCA2 (tBRCA) or non-tBRCA high loss of heterozygosity (LOHhigh). Presented here are data for the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants	OG000185 OG00149

Title

Denominators

Categories

Title	Measurements
	OG00028.7(23.0 to NA)Not reached due to insufficient number of events OG00111.3(9.1 to 22.1)

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		Log Rank		0.0004		Hazard Ratio (HR)	0.47			2-Sided	95	0.31	0.72			The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.		Superiority	Rucaparib vs Placebo

Primary

Monotherapy Arm B and Arm D: Investigator Assessed PFS

PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

The ITT population included all randomized participants. Presented here are data for the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants

Primary

Combination Therapy Arm A and Arm B: Investigator Assessed PFS

PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B).

Posted

Median

95% Confidence Interval

months

From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

ID	Title	Description
OG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
OG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants

Secondary

Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS

PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants

Secondary

Monotherapy Arm B and Arm D: BICR PFS

PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants

Secondary

Combination Therapy Arm A and Arm B: BICR PFS

PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

BICR was included as a supportive secondary endpoint in the event that the Investigator-assessed PFS result was positive. In the ATHENA-COMBO statistical analysis plan it was specified that the BICR analysis would only be performed if the primary endpoint of Investigator-assessed PFS was statistically significant. Given that the result was negative and not statistically significant, the analysis of BICR was not performed, thus that data is not available and cannot be provided.

Posted

From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

ID	Title	Description
OG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
OG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.

Secondary

Monotherapy Arm B and Arm D: Overall Survival (OS)

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants	OG000

Secondary

Monotherapy Arm B and Arm D: OS

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

Posted

Median

95% Confidence Interval

months

From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants	OG000

Secondary

Combination Therapy Arm A and Arm B: OS

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B).

Posted

Median

95% Confidence Interval

months

From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)

ID	Title	Description
OG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
OG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts
Participants	OG000

Secondary

Monotherapy Arm B and Arm D: Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Secondary

Monotherapy Arm B and Arm D: ORR

ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Units	Counts

Secondary

Combination Therapy Arm A and Arm B: ORR

ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

ID	Title	Description
OG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
OG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.

Units

Secondary

Monotherapy Arm B and Arm D: Duration of Response (DOR)

DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Posted

Number

95% Confidence Interval

months

From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Secondary

Monotherapy Arm B and Arm D: DOR

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Posted

Number

95% Confidence Interval

months

From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)

ID	Title	Description
OG000	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
OG001	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.

Secondary

Combination Therapy Arm A and Arm B: DOR

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

The ITT population included all randomized participants. Presented here are data from the combination comparison arms (Arm A and Arm B). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

Posted

Number

95% Confidence Interval

months

From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)

ID	Title	Description
OG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
OG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG00035 events23 affected410 at risk EG00120 events18 affected448 at risk EG0020 events0 affected107 at risk EG0030 events0 affected111 at risk EG0040 events0 affected15 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG00037 events30 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0005 events4 affected410 at risk EG0016 events6 affected448 at risk EG0020 events0 affected107 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG00010 events10 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0005 events4 affected410 at risk EG0014 events4 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Hypopituitarism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Age-related macular degeneration	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cataract	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Iritis	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Uveitis	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Vogt-Koyanagi-Harada disease	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0005 events5 affected410 at risk EG0015 events5 affected448 at risk EG0021 events1 affected107 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Appendix disorder	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0012 events1 affected448 at risk EG0022 events1 affected107 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0015 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Megacolon	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0004 events3 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00014 events11 affected410 at risk EG0015 events5 affected448 at risk EG0020 events0 affected107 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0014 events4 affected448 at risk EG0020 events0 affected107 at risk EG003
Asthenia	General disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Fatigue	General disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Pyrexia	General disorders	MedDRA v27.0	Systematic Assessment	EG00010 events8 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Appendicitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Bacteraemia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Brucellosis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0013 events3 affected448 at risk EG0021 events1 affected107 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Catheter site infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Cystitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Device related infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0021 events1 affected107 at risk EG003
Encephalitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Infected lymphocele	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Influenza	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Meningitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected410 at risk EG0014 events4 affected448 at risk EG0022 events2 affected107 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Sepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Skin infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0007 events6 affected410 at risk EG0016 events6 affected448 at risk EG0020 events0 affected107 at risk EG003
Urosepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Vaginal infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Viral infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0022 events1 affected107 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Product administration error	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Stoma prolapse	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0009 events8 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0007 events6 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Blood bilirubin increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Blood creatinine increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
C-reactive protein increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Liver function test increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Platelet count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0005 events3 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0013 events2 affected448 at risk EG0021 events1 affected107 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Seronegative arthritis	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG00116 events16 affected448 at risk EG0023 events3 affected107 at risk EG003
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Bell's palsy	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Brain oedema	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Headache	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Paraneoplastic neurological syndrome	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Syncope	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0011 events1 affected448 at risk EG0021 events1 affected107 at risk EG003
Delirium	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0007 events6 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0004 events4 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0013 events3 affected448 at risk EG0021 events1 affected107 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Embolism	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Haematoma	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypertension	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG000789 events198 affected410 at risk EG001778 events198 affected448 at risk EG00223 events10 affected107 at risk EG00323 events11 affected111 at risk EG00449 events12 affected15 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG000118 events40 affected410 at risk EG00169 events18 affected448 at risk EG0021 events1 affected107 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG00021 events12 affected410 at risk EG00120 events9 affected448 at risk EG0020 events0 affected107 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG000300 events89 affected410 at risk EG001216 events65 affected448 at risk EG0025 events5 affected107 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG000198 events78 affected410 at risk EG001126 events51 affected448 at risk EG0022 events2 affected107 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v27.0	Systematic Assessment	EG0009 events8 affected410 at risk EG0016 events6 affected448 at risk EG0022 events2 affected107 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0011 events1 affected448 at risk EG0021 events1 affected107 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG00033 events26 affected410 at risk EG0013 events3 affected448 at risk EG00212 events11 affected107 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG00057 events40 affected410 at risk EG00114 events12 affected448 at risk EG00219 events14 affected107 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Eye disorder	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Uveitis	Eye disorders	MedDRA v27.0	Systematic Assessment	EG00024 events15 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Vitreous floaters	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0004 events4 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00040 events33 affected410 at risk EG00156 events44 affected448 at risk EG0023 events3 affected107 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG000139 events91 affected410 at risk EG001146 events109 affected448 at risk EG00221 events15 affected107 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00046 events35 affected410 at risk EG00155 events42 affected448 at risk EG0025 events5 affected107 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG000137 events100 affected410 at risk EG001125 events85 affected448 at risk EG00212 events11 affected107 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0004 events3 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG000217 events113 affected410 at risk EG001181 events107 affected448 at risk EG00234 events20 affected107 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00022 events20 affected410 at risk EG00116 events16 affected448 at risk EG00211 events7 affected107 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00038 events30 affected410 at risk EG00155 events44 affected448 at risk EG0025 events5 affected107 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00018 events15 affected410 at risk EG00123 events21 affected448 at risk EG0026 events5 affected107 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0007 events7 affected410 at risk EG0017 events7 affected448 at risk EG0023 events2 affected107 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG000458 events234 affected410 at risk EG001457 events254 affected448 at risk EG00232 events27 affected107 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG00059 events38 affected410 at risk EG00172 events34 affected448 at risk EG00210 events7 affected107 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG000226 events128 affected410 at risk EG001187 events107 affected448 at risk EG00216 events11 affected107 at risk EG003
Asthenia	General disorders	MedDRA v27.0	Systematic Assessment	EG000117 events56 affected410 at risk EG001114 events62 affected448 at risk EG00211 events7 affected107 at risk EG003
Fatigue	General disorders	MedDRA v27.0	Systematic Assessment	EG000384 events186 affected410 at risk EG001344 events189 affected448 at risk EG00236 events24 affected107 at risk EG003
Malaise	General disorders	MedDRA v27.0	Systematic Assessment	EG00023 events15 affected410 at risk EG00124 events13 affected448 at risk EG0024 events2 affected107 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected410 at risk EG0011 events1 affected448 at risk EG0021 events1 affected107 at risk EG003
Oedema	General disorders	MedDRA v27.0	Systematic Assessment	EG00011 events10 affected410 at risk EG0015 events5 affected448 at risk EG0024 events4 affected107 at risk EG003
Oedema peripheral	General disorders	MedDRA v27.0	Systematic Assessment	EG00045 events32 affected410 at risk EG00145 events34 affected448 at risk EG0024 events4 affected107 at risk EG003
Pyrexia	General disorders	MedDRA v27.0	Systematic Assessment	EG00097 events65 affected410 at risk EG00151 events41 affected448 at risk EG0029 events9 affected107 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG00034 events30 affected410 at risk EG00129 events27 affected448 at risk EG0023 events3 affected107 at risk EG003
Cystitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0009 events7 affected410 at risk EG00113 events12 affected448 at risk EG0022 events2 affected107 at risk EG003
Hordeolum	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0013 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Influenza	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0005 events5 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG00021 events16 affected410 at risk EG00136 events22 affected448 at risk EG0022 events2 affected107 at risk EG003
Papilloma viral infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Paronychia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected410 at risk EG0011 events1 affected448 at risk EG0024 events3 affected107 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG00041 events33 affected410 at risk EG00130 events24 affected448 at risk EG0029 events8 affected107 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG00080 events52 affected410 at risk EG00153 events41 affected448 at risk EG00220 events12 affected107 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0010 events0 affected448 at risk EG0020 events0 affected107 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0010 events0 affected448 at risk EG0021 events1 affected107 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG000614 events212 affected410 at risk EG001464 events178 affected448 at risk EG00228 events17 affected107 at risk EG003
Amylase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0004 events2 affected410 at risk EG0010 events0 affected448 at risk EG0023 events1 affected107 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG000452 events197 affected410 at risk EG001341 events161 affected448 at risk EG00226 events15 affected107 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG00069 events41 affected410 at risk EG00156 events42 affected448 at risk EG0023 events2 affected107 at risk EG003
Blood bilirubin increased	Investigations	MedDRA v27.0	Systematic Assessment	EG00080 events31 affected410 at risk EG00140 events19 affected448 at risk EG0020 events0 affected107 at risk EG003
Blood cholesterol increased	Investigations	MedDRA v27.0	Systematic Assessment	EG00048 events30 affected410 at risk EG00169 events27 affected448 at risk EG00212 events5 affected107 at risk EG003
Blood creatinine increased	Investigations	MedDRA v27.0	Systematic Assessment	EG000162 events66 affected410 at risk EG001108 events52 affected448 at risk EG0028 events7 affected107 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG00014 events9 affected410 at risk EG00115 events9 affected448 at risk EG0021 events1 affected107 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG00033 events18 affected410 at risk EG00126 events12 affected448 at risk EG0020 events0 affected107 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG000309 events69 affected410 at risk EG001223 events61 affected448 at risk EG00215 events6 affected107 at risk EG003
Platelet count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG000240 events65 affected410 at risk EG001185 events59 affected448 at risk EG0027 events2 affected107 at risk EG003
White blood cell count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG000217 events58 affected410 at risk EG001135 events40 affected448 at risk EG0022 events2 affected107 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG000126 events80 affected410 at risk EG001111 events80 affected448 at risk EG00213 events7 affected107 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0006 events4 affected410 at risk EG0013 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG00028 events14 affected410 at risk EG00152 events26 affected448 at risk EG0025 events5 affected107 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG00028 events19 affected410 at risk EG00129 events21 affected448 at risk EG0021 events1 affected107 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG00039 events30 affected410 at risk EG00134 events23 affected448 at risk EG0022 events2 affected107 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG00047 events25 affected410 at risk EG00152 events32 affected448 at risk EG00210 events4 affected107 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG00034 events19 affected410 at risk EG00136 events14 affected448 at risk EG0022 events1 affected107 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG000162 events99 affected410 at risk EG001142 events92 affected448 at risk EG00242 events24 affected107 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0008 events6 affected410 at risk EG00111 events10 affected448 at risk EG0022 events1 affected107 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG00070 events53 affected410 at risk EG00162 events45 affected448 at risk EG00211 events11 affected107 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0005 events5 affected410 at risk EG00111 events9 affected448 at risk EG0020 events0 affected107 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG00022 events15 affected410 at risk EG00117 events13 affected448 at risk EG0024 events3 affected107 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG00059 events37 affected410 at risk EG00176 events54 affected448 at risk EG0025 events3 affected107 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG00038 events27 affected410 at risk EG00155 events40 affected448 at risk EG0024 events4 affected107 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected410 at risk EG0014 events4 affected448 at risk EG0020 events0 affected107 at risk EG003
Dizziness	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG00082 events65 affected410 at risk EG00181 events59 affected448 at risk EG00213 events12 affected107 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG000100 events81 affected410 at risk EG001125 events91 affected448 at risk EG0028 events7 affected107 at risk EG003
Headache	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG000127 events78 affected410 at risk EG001151 events88 affected448 at risk EG00210 events9 affected107 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG00011 events9 affected410 at risk EG00111 events11 affected448 at risk EG0022 events2 affected107 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG00035 events24 affected410 at risk EG00145 events37 affected448 at risk EG00214 events8 affected107 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected410 at risk EG0016 events6 affected448 at risk EG0020 events0 affected107 at risk EG003
Somnolence	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0006 events6 affected410 at risk EG0012 events2 affected448 at risk EG0020 events0 affected107 at risk EG003
Taste disorder	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG00025 events21 affected410 at risk EG00124 events24 affected448 at risk EG0020 events0 affected107 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG00028 events25 affected410 at risk EG00124 events20 affected448 at risk EG0022 events2 affected107 at risk EG003
Depression	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG00021 events18 affected410 at risk EG00120 events18 affected448 at risk EG0026 events6 affected107 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG00063 events56 affected410 at risk EG00184 events62 affected448 at risk EG0029 events8 affected107 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG00075 events55 affected410 at risk EG00175 events56 affected448 at risk EG0026 events6 affected107 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG000106 events67 affected410 at risk EG00178 events51 affected448 at risk EG00214 events13 affected107 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG00029 events25 affected410 at risk EG00119 events13 affected448 at risk EG0025 events4 affected107 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG00010 events9 affected410 at risk EG00114 events14 affected448 at risk EG0022 events1 affected107 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0007 events4 affected410 at risk EG0015 events3 affected448 at risk EG0020 events0 affected107 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG00031 events22 affected410 at risk EG00131 events23 affected448 at risk EG0025 events5 affected107 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG00040 events26 affected410 at risk EG00135 events31 affected448 at risk EG0021 events1 affected107 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected410 at risk EG0011 events1 affected448 at risk EG0020 events0 affected107 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG000119 events76 affected410 at risk EG001106 events71 affected448 at risk EG0028 events8 affected107 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG000121 events72 affected410 at risk EG00195 events65 affected448 at risk EG00232 events17 affected107 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG00074 events37 affected410 at risk EG00112 events7 affected448 at risk EG0025 events2 affected107 at risk EG003
Hot flush	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG00017 events15 affected410 at risk EG00138 events32 affected448 at risk EG0022 events2 affected107 at risk EG003
Hypertension	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG00039 events26 affected410 at risk EG00146 events26 affected448 at risk EG00212 events4 affected107 at risk EG003
Lymphoedema	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0004 events2 affected410 at risk EG0012 events2 affected448 at risk EG0021 events1 affected107 at risk EG003

ID	Title	Description
BG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
BG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.
BG002	Arm C: Placebo + Nivolumab	Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks
BG003	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
BG004	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
BG005	Total	Total of all reporting groups

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube Neoplasms
D000095384	Pathologic Complete Response
D009369	Neoplasms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D010051	Ovarian Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases
D018450	Disease Progression
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	12	410	154	410	406	410
EG001	Arm B: Rucaparib + Placebo	Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	20	448	117	448	433	448
EG002	Arm C: Placebo + Nivolumab	Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks.	4	107	18	107	99	107
EG003	Arm D: Placebo + Placebo	Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	2	111	13	111	103	111
EG004	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab	Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	0	15	4	15	15	15