A Study of Niraparib (GSK3985771) Maintenance Treatment i... | NCT02655016

NCT02655016

ID	Type	Description	Link
PR-30-5017-C	Other Identifier	Tesaro
2023-508010-42	Other Identifier	CTIS

Status Module

Name	Class
Gynecologic Oncology Group	NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER
Myriad Genetics, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Participants receiving Niraparib	Experimental		Drug: Niraparib
Participants receiving Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Niraparib	Drug	Niraparib will be administered.	Participants receiving Niraparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival	Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.	Up to 34 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.	Up to 34 months
Time to First Subsequent Therapy (TFST)

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE	An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria.
Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery.
Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (>=)6 and less than or equal to (<=)9 cycles of platinum-based therapy; Participants must have had >=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after >=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (>)15% from nadir).
Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.
All participants must agree to undergo central tumor HRD testing.
Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the first dose of study treatment.

Exclusion criteria:

Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer.
Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery.
Participant has undergone more than two debulking surgeries for the study disease.
Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.
Participant has a known hypersensitivity to the components of niraparib or its excipients.
Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor.
Participant is to receive bevacizumab as maintenance treatment.
Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
Participant has had any known >=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted >4 weeks.
Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including:
1. Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.
2. Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Tempe	Arizona	85284	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
39284381	Background	Monk BJ, Barretina-Ginesta MP, Pothuri B, Vergote I, Graybill W, Mirza MR, McCormick CC, Lorusso D, Moore RG, Freyer G, O'Cearbhaill RE, Heitz F, O'Malley DM, Redondo A, Shahin MS, Vulsteke C, Bradley WH, Haslund CA, Chase DM, Pisano C, Holman LL, Perez MJR, DiSilvestro P, Gaba L, Herzog TJ, Bruchim I, Compton N, Shtessel L, Malinowska IA, Gonzalez-Martin A. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Ann Oncol. 2024 Nov;35(11):981-992. doi: 10.1016/j.annonc.2024.08.2241. Epub 2024 Sep 14.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 27, 2019	Apr 27, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
BG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
BG002	Total	Total of all reporting groups

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

Progression Free Survival

Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

Intent-to-Treat (ITT) population comprised of all participants who were randomized into the study.

Posted

Median

95% Confidence Interval

Months

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
OG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Units	Counts
Participants	OG000246 OG001487

Title

Denominators

Categories

Title	Measurements
	OG0008.2(7.3 to 8.5) OG00113.8(11.5 to 14.9)

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		<0.0001	p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.	Hazard Ratio (HR)	0.62			2-Sided	95	0.502	0.755			If hazard ratio was found to be <1 then niraparib can be considered as superior to placebo.		Superiority

Secondary

Overall Survival

Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.

ITT Population

Posted

Median

95% Confidence Interval

Months

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
OG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Time to First Subsequent Therapy (TFST)

Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.

ITT Population

Posted

Median

95% Confidence Interval

Months

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
OG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Progression-Free Survival-2 (PFS2)

PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.

ITT Population

Posted

Median

95% Confidence Interval

Months

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
OG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)

FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score

The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)

EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal [GI] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Secondary

Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28

EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Day 1, Pre-dose) and Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Other Pre-specified

Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE

An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.

Safety Population comprised of all participants who received at least 1 dose of study drug. 5 participants (2 participants from Placebo group and 3 participants from Niraparib group) out of 733 participants did not receive any study treatment and thus, were excluded from the Safety Population.

Posted

Count of Participants

Participants

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Other Pre-specified

Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])

Blood samples were planned to be collected for assessment of AUC(0-last).

ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Posted

Up to 34 months

ID	Title	Description
OG000	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Units	Counts
Participants	OG000

Other Pre-specified

Peak Plasma Concentration (Cmax)

Blood samples were planned to be collected for assessment of Cmax.

ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Posted

Up to 34 months

ID	Title	Description
OG000	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Positive HRD Test

Number of participants with positive HRD test was planned to be assessed.

ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Posted

Up to 34 months

ID	Title	Description
OG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
OG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).	31	244	32	244	223	244
EG001	Niraparib	Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).	48	484	156	484	478	484

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00128 events27 affected484 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0016 events6 affected484 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00165 events59 affected484 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Abdominal fat apron	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Enteritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0016 events5 affected484 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG00119 events14 affected484 at risk
Subileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Infected lymphocele	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Pneumonia fungal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Skin bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG00110 events8 affected484 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
International normalised ratio increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Platelet count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00125 events20 affected484 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Metastases to breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Aphasia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Device occlusion	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mania	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events1 affected484 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Fasting	Social circumstances	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lymphocele	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00083 events43 affected244 at risk EG001921 events306 affected484 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Haemorrhagic disorder	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00027 events13 affected244 at risk EG001145 events57 affected484 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00140 events12 affected484 at risk
Macrocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00032 events16 affected244 at risk EG001366 events126 affected484 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00012 events9 affected244 at risk EG001549 events210 affected484 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Conduction disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Metabolic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected244 at risk EG00145 events39 affected484 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 events3 affected244 at risk EG00117 events12 affected484 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected244 at risk EG00128 events25 affected484 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Deafness	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0016 events6 affected484 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
External ear pain	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Paraesthesia ear	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected244 at risk EG00111 events11 affected484 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0007 events6 affected244 at risk EG00113 events13 affected484 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected484 at risk
Thyroid cyst	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Thyroid mass	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Age-related macular degeneration	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blepharospasm	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected484 at risk
Cataract nuclear	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Diplopia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dry eye	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00112 events11 affected484 at risk
Eye disorder	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Eye haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Eye oedema	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Eye pain	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0015 events4 affected484 at risk
Eye swelling	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Eyelid oedema	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Eyelid sensory disorder	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hypermetropia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lacrimation increased	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events1 affected484 at risk
Myopia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ocular discomfort	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Ocular hyperaemia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0015 events2 affected484 at risk
Photophobia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Photopsia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Retinal exudates	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Retinal haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Scleral disorder	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0015 events5 affected484 at risk
Visual acuity reduced	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Visual impairment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0015 events5 affected484 at risk
Vitreous floaters	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00011 events11 affected244 at risk EG00119 events15 affected484 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00036 events30 affected244 at risk EG00136 events32 affected484 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0015 events4 affected484 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG000102 events74 affected244 at risk EG001146 events105 affected484 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00017 events13 affected244 at risk EG00116 events15 affected484 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00026 events21 affected244 at risk EG00159 events41 affected484 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0016 events4 affected484 at risk
Abnormal faeces	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Aerophagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0011 events1 affected484 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0015 events5 affected484 at risk
Ascites	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected244 at risk EG0013 events3 affected484 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00052 events46 affected244 at risk EG001262 events189 affected484 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00082 events55 affected244 at risk EG001132 events91 affected484 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 events6 affected244 at risk EG00146 events40 affected484 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00016 events14 affected244 at risk EG00143 events34 affected484 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00110 events6 affected484 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Eructation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0013 events3 affected484 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Flatulence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 events7 affected244 at risk EG00120 events17 affected484 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0015 events5 affected484 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 events7 affected244 at risk EG00128 events25 affected484 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Glossitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0011 events1 affected484 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events3 affected244 at risk EG0013 events3 affected484 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0016 events5 affected484 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0014 events4 affected484 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Lip blister	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Lip disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0015 events4 affected484 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG000100 events67 affected244 at risk EG001448 events278 affected484 at risk
Noninfective gingivitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oral contusion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Oral mucosal blistering	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events2 affected484 at risk
Oral mucosal discolouration	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Oral pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0019 events7 affected484 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0017 events5 affected484 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Regurgitation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Retching	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Salivary duct stenosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0011 events1 affected484 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0007 events4 affected244 at risk EG00118 events16 affected484 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0016 events6 affected484 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0013 events3 affected484 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00034 events28 affected244 at risk EG001153 events108 affected484 at risk
Adhesion	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG00047 events31 affected244 at risk EG001138 events78 affected484 at risk
Axillary pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Catheter site bruise	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Catheter site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Catheter site pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Catheter site rash	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Catheter site vesicles	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Chest discomfort	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0015 events5 affected484 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0014 events3 affected484 at risk
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0017 events6 affected484 at risk
Cyst	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Discomfort	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events3 affected484 at risk
Early satiety	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0014 events4 affected484 at risk
Facial pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG000101 events72 affected244 at risk EG001242 events168 affected484 at risk
Feeling abnormal	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Feeling hot	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Generalised oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hernia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Hernia pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Induration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG00012 events11 affected244 at risk EG00122 events15 affected484 at risk
Injection site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Local swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0017 events7 affected484 at risk
Mass	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mucosal dryness	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG00010 events6 affected244 at risk EG00129 events23 affected484 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00115 events13 affected484 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG00019 events11 affected244 at risk EG00135 events30 affected484 at risk
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected244 at risk EG00117 events16 affected484 at risk
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0016 events6 affected484 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG00017 events15 affected244 at risk EG00147 events41 affected484 at risk
Secretion discharge	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sensation of foreign body	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Suprapubic pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ulcer	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Unevaluable event	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Vessel puncture site bruise	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vessel puncture site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events1 affected484 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0018 events2 affected484 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Contrast media allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Contrast media reaction	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Seasonal allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG0013 events3 affected484 at risk
Abdominal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Acute sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Anal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Angular cheilitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Arthritis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00113 events12 affected484 at risk
Candida infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected244 at risk EG0012 events2 affected484 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0017 events5 affected484 at risk
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0016 events6 affected484 at risk
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ear infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Eye infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Folliculitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected244 at risk EG0010 events0 affected484 at risk
Fungal skin infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Furuncle	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Gastric infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Gastrointestinal candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Genital herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Gingivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected244 at risk EG0012 events2 affected484 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0018 events5 affected484 at risk
Hordeolum	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG0016 events6 affected484 at risk
Laryngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Localised infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Lymphangitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Mastitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Medical device site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mucosal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nail infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Onychomycosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Ophthalmic herpes simplex	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Oral fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG00110 events7 affected484 at risk
Oral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Otitis externa	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Otitis media	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Paronychia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0010 events0 affected484 at risk
Pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0016 events5 affected484 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0019 events8 affected484 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0013 events3 affected484 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Rhinitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00110 events9 affected484 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Shigella infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sialoadenitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0007 events7 affected244 at risk EG00127 events15 affected484 at risk
Skin candida	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Skin infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Soft tissue infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tinea pedis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Tooth abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tooth infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0019 events7 affected484 at risk
Tracheitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00022 events18 affected244 at risk EG00131 events28 affected484 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00025 events19 affected244 at risk EG00148 events44 affected484 at risk
Vaginal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0014 events3 affected484 at risk
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00040 events25 affected244 at risk EG00155 events49 affected484 at risk
Vulvitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 events3 affected244 at risk EG00129 events22 affected484 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00114 events12 affected484 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0011 events1 affected484 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Incision site swelling	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected484 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Mallet finger	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0011 events1 affected484 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG0016 events6 affected484 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0010 events0 affected484 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Stoma complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Stoma site discharge	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Stoma site inflammation	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events2 affected484 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vascular access malfunction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Alanine aminotransferase	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00021 events15 affected244 at risk EG00167 events42 affected484 at risk
Amylase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Aspartate aminotransferase	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events1 affected484 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00016 events10 affected244 at risk EG00178 events43 affected484 at risk
Bilirubin conjugated increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Blood alkaline phosphatase	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0008 events6 affected244 at risk EG00166 events42 affected484 at risk
Blood bilirubin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00113 events7 affected484 at risk
Blood calcium increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood chloride increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood cholesterol increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Blood creatine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00012 events10 affected244 at risk EG00196 events55 affected484 at risk
Blood glucose decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood glucose increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0016 events4 affected484 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Blood magnesium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Blood potassium increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0015 events5 affected484 at risk
Blood sodium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood urea increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected244 at risk EG0014 events4 affected484 at risk
Bone density decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Carbohydrate antigen 125 increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00011 events10 affected244 at risk EG0017 events7 affected484 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Eosinophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00121 events11 affected484 at risk
Haematocrit decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0017 events5 affected484 at risk
Heart rate increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00110 events9 affected484 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Intraocular pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lipase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Lymphocyte count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG00143 events25 affected484 at risk
Mean cell volume increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Monocyte count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Monocyte count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG00010 events5 affected244 at risk EG001207 events82 affected484 at risk
Neutrophil count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Platelet count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG001338 events129 affected484 at risk
Platelet count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Protein total decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Red blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Sputum abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vitamin D decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected244 at risk EG00127 events20 affected484 at risk
Weight increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00030 events19 affected244 at risk EG00124 events17 affected484 at risk
White blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG00016 events8 affected244 at risk EG001205 events74 affected484 at risk
White blood cell count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Cell death	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00021 events20 affected244 at risk EG001112 events92 affected484 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0017 events6 affected484 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG00114 events9 affected484 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0017 events7 affected484 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0008 events6 affected244 at risk EG00128 events19 affected484 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG00110 events6 affected484 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hyperproteinaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0006 events3 affected244 at risk EG00113 events8 affected484 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events2 affected484 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0012 events2 affected484 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG00137 events25 affected484 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00018 events12 affected244 at risk EG00158 events38 affected484 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG00135 events19 affected484 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00110 events2 affected484 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0010 events0 affected484 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Magnesium deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00077 events47 affected244 at risk EG001116 events85 affected484 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected244 at risk EG0016 events6 affected484 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00029 events24 affected244 at risk EG00184 events64 affected484 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected244 at risk EG0012 events2 affected484 at risk
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Extremity contracture	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected244 at risk EG0018 events7 affected484 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0015 events5 affected484 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0007 events4 affected244 at risk EG0014 events4 affected484 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0019 events7 affected484 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0011 events1 affected484 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00025 events14 affected244 at risk EG00124 events19 affected484 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG00115 events12 affected484 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00010 events9 affected244 at risk EG00117 events12 affected484 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00011 events8 affected244 at risk EG00115 events12 affected484 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events1 affected244 at risk EG0018 events7 affected484 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00018 events13 affected244 at risk EG00149 events36 affected484 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0009 events7 affected244 at risk EG00113 events12 affected484 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00110 events8 affected484 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected484 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00115 events14 affected484 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00020 events16 affected244 at risk EG00153 events38 affected484 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0013 events3 affected484 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG0011 events1 affected484 at risk
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected244 at risk EG0012 events2 affected484 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vaginal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Amnesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Aphasia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Aphonia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Aura	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Balance disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0016 events6 affected484 at risk
Burning sensation	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 events3 affected244 at risk EG0013 events3 affected484 at risk
Cognitive disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Disturbance in attention	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00030 events26 affected244 at risk EG00196 events71 affected484 at risk
Dizziness postural	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Dysaesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events1 affected484 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00013 events10 affected244 at risk EG00134 events25 affected484 at risk
Dyskinesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Facial nerve disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00046 events36 affected244 at risk EG001190 events126 affected484 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected244 at risk EG00112 events8 affected484 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Memory impairment	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG0017 events7 affected484 at risk
Mental impairment	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Migraine	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG0015 events4 affected484 at risk
Motor dysfunction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00018 events15 affected244 at risk EG00138 events31 affected484 at risk
Neurotoxicity	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0011 events1 affected484 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0009 events8 affected244 at risk EG00120 events11 affected484 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00010 events8 affected244 at risk EG00121 events18 affected484 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0013 events2 affected484 at risk
Radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG00110 events9 affected484 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sinus headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Speech disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0016 events5 affected484 at risk
Tension headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Transient global amnesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Tremor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0019 events7 affected484 at risk
Agitation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00111 events8 affected484 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG00024 events19 affected244 at risk EG00153 events43 affected484 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Depressed mood	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0012 events2 affected484 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG00014 events10 affected244 at risk EG00128 events26 affected484 at risk
Dysphoria	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Emotional disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Genito-pelvic pain/penetration disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hallucination	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Hallucination, olfactory	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Initial insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG00037 events35 affected244 at risk EG001162 events119 affected484 at risk
Irritability	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Libido decreased	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Libido increased	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mania	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Mood swings	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nervousness	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Nightmare	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Panic attack	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Restlessness	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Sleep disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events3 affected484 at risk
Stress	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Azotaemia	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Bladder discomfort	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Bladder pain	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Cystitis interstitial	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Dysuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG00011 events10 affected244 at risk EG00122 events21 affected484 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected244 at risk EG0016 events5 affected484 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events2 affected484 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0013 events3 affected484 at risk
Nephritis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Nephropathy	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nocturia	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG00111 events11 affected484 at risk
Polyuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected244 at risk EG0011 events1 affected484 at risk
Proteinuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Renal colic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Renal pain	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Urethral pain	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Breast calcifications	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Breast discharge	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0011 events1 affected484 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events2 affected484 at risk
Coital bleeding	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Genital paraesthesia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Genital swelling	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0007 events6 affected244 at risk EG0018 events8 affected484 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0016 events4 affected484 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0013 events3 affected484 at risk
Vaginal mucosal blistering	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Vulvovaginal burning sensation	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected244 at risk EG00112 events7 affected484 at risk
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0011 events1 affected484 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00045 events35 affected244 at risk EG00192 events74 affected484 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0014 events4 affected484 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00033 events30 affected244 at risk EG001129 events88 affected484 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG00118 events17 affected484 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events3 affected244 at risk EG00124 events23 affected484 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 events9 affected244 at risk EG00128 events21 affected484 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nasal pruritus	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00019 events18 affected244 at risk EG00124 events22 affected484 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0013 events2 affected484 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0014 events2 affected484 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG00116 events14 affected484 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0013 events3 affected484 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0017 events6 affected484 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0019 events9 affected484 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG0013 events2 affected484 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events2 affected484 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected244 at risk EG0012 events2 affected484 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG0017 events7 affected484 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events1 affected484 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00012 events11 affected244 at risk EG00121 events19 affected484 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0014 events4 affected484 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events2 affected244 at risk EG0012 events2 affected484 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0019 events6 affected484 at risk
Erythema dyschromicum perstans	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Hair texture abnormal	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events1 affected484 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected244 at risk EG0018 events8 affected484 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Hypertrichosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events2 affected484 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Nail growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected244 at risk EG0015 events5 affected484 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG00129 events28 affected484 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG00135 events29 affected484 at risk
Pityriasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events1 affected244 at risk EG0010 events0 affected484 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00021 events19 affected244 at risk EG00118 events13 affected484 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected244 at risk EG0014 events4 affected484 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events3 affected484 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00012 events8 affected244 at risk EG00129 events23 affected484 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected484 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected244 at risk EG00114 events12 affected484 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Sebaceous gland disorder	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0012 events2 affected484 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Solar lentigo	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0014 events4 affected484 at risk
Astringent therapy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected484 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Flushing	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected244 at risk EG0013 events3 affected484 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0017 events7 affected484 at risk
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00020 events20 affected244 at risk EG00164 events54 affected484 at risk
Hyperaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00028 events17 affected244 at risk EG001142 events81 affected484 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected244 at risk EG0011 events1 affected484 at risk
Lymphocele	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Lymphoedema	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected244 at risk EG0011 events1 affected484 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0013 events3 affected484 at risk
Pallor	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected484 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Phlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0011 events1 affected484 at risk
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected244 at risk EG0011 events1 affected484 at risk
Varicose vein	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected244 at risk EG0013 events3 affected484 at risk

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
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