LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combina... | NCT01015118

NCT01015118

ID	Type	Description	Link
AGO-OVAR12	Other Identifier	OTHER
2008-006831-10	EudraCT Number	EudraCT

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIBF 1120	Experimental	patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel	Drug: BIBF 1120 Drug: Paclitaxel Drug: Carboplatin
Placebo	Placebo Comparator	patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel	Drug: Placebo Drug: Paclitaxel Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	comparator to BIBF 1120	Placebo
Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.	Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.	First drug administration to date of disease progression or death whichever occurs first , upto 29 months
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).	Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.	First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

Secondary Outcomes

Measure	Description	Time Frame
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).	Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV
females, age 18 years or older
life expectancy of at least 6 months
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)
patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation
planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery

Exclusion criteria:

histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum
planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery
clinically relevant non-healing wound, ulcer or bone fracture
clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
brain metastases
pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma
history of major thromboembolic event
known inherited or acquired bleeding disorder
significant cardiovascular diseases
clinically relevant pericardial effusion
history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months
inadequate safety laboratory values
serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)
poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy
gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer
prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)
prior systemic cytotoxic chemotherapy
prior treatment with BIBF 1120 or any other angiogenesis inhibitor
prior radiotherapy
serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration
Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.
pregnancy or breast feeding
psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
active alcohol or drug abuse
patients unable to comply with the protocol
any contraindications for therapy with paclitaxel or carboplatin
treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1199.15.10113 Boehringer Ingelheim Investigational Site		Tucson	Arizona		United States
1199.15.10030 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37185961	Derived	Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
26590673	Derived	du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidzinski M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjorge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Randomised Set (RS): included all randomised patients, regardless of whether or not they had received treatment. Patients were assigned to nintedanib or placebo as randomised.

Arm/Group Information

ID	Title	Description
BG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
BG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00017.2(11.1 to 32.5) OG00116.6(10.8 to 30.4)

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	Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).	Log Rank	Breslow method was used for handling ties.	0.0239		Hazard Ratio (HR)	0.84			2-Sided	95	0.72	0.98			If hazard ratio is below 1 then favours nintedanib.		Superiority or Other

Primary

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).

Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.

Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Randomised Set (RS)

Posted

Median

Inter-Quartile Range

Months

First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Secondary

PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).

Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.

The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.

Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Randomised Set (RS)

Posted

Median

Inter-Quartile Range

Months

First drug administration to date of disease progression or death whichever occurs first , upto 29 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Secondary

PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).

Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Randomised Set (RS)

Posted

Median

Inter-Quartile Range

Months

First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Secondary

Overall Survival

Overall survival is defined as time from randomization to date of death (irrespective of reason).

Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Randomised Set (RS)

Posted

Median

Inter-Quartile Range

Months

First drug administration to date of death until final DBL 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Units	Counts
Participants	OG000

Secondary

Time to CA-125 Tumour Marker Progression

Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN.

Randomised set (RS)

Posted

Median

Inter-Quartile Range

Months

First drug administration until final DBL 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Units	Counts
Participants

Secondary

Objective Response Based on Investigator Assessment

Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline

Randomised Set (RS) for patients with at least 1 target lesion reported at baseline

Posted

Number

percentage of participants

First drug administration until final DBL 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Units	Counts
Participants

Secondary

Change in Abdominal/Gastro-intestinal Symptoms Over Time

Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).

As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).

Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).

Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms

Posted

Mean

Standard Error

units on a scale

First drug administration until final DBL 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Secondary

Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.

Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.

Randomised Set (RS) for patients with global health status/QoL

Posted

Mean

Standard Error

units on a scale

First drug administration until final DBL 26September16, upto 62 months

ID	Title	Description
OG000	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
OG001	Placebo	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

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	Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.			157	450	442	450
EG001	Nintedanib	Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.			379	902	891	902

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0009 affected450 at risk EG00136 affected902 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected450 at risk EG00120 affected902 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0018 affected902 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected450 at risk EG00124 affected902 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0018 affected902 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Splenic vein thrombosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected450 at risk EG00121 affected902 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Bundle branch block left	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0013 affected902 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Palpitations	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cancer gene carrier	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Deafness	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Goitre	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vision blurred	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0012 affected902 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected450 at risk EG00130 affected902 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0018 affected902 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ascites	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected450 at risk EG00114 affected902 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00010 affected450 at risk EG00113 affected902 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected450 at risk EG00141 affected902 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Fistula of small intestine	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0012 affected902 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected450 at risk EG00117 affected902 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected450 at risk EG0017 affected902 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0015 affected902 at risk
Intussusception	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00010 affected450 at risk EG00124 affected902 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected450 at risk EG00112 affected902 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Subileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0018 affected902 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00012 affected450 at risk EG00133 affected902 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG00113 affected902 at risk
Catheter site haematoma	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected450 at risk EG0014 affected902 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cyst	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Death	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG00110 affected902 at risk
General physical health deterioration	General disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected450 at risk EG00117 affected902 at risk
Hernia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Impaired healing	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Implant site erythema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Influenza like illness	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Infusion site extravasation	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Nodule	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Performance status decreased	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected450 at risk EG00123 affected902 at risk
Sudden death	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Surgical failure	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0014 affected902 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Anaphylactoid reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Contrast media allergy	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG0019 affected902 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Abdominal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Clostridial infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Cystitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0016 affected902 at risk
Device related infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG0014 affected902 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Enteritis infectious	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Enterobacter infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Erysipelas	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Febrile infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG0014 affected902 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Infected lymphocele	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0013 affected902 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Joint abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Klebsiella infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Liver abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Lung infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Mesenteric abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Pelvic abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG0016 affected902 at risk
Postoperative abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pulpitis dental	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0012 affected902 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Rectal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0014 affected902 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Tooth abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG00117 affected902 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Urosepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0012 affected902 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0004 affected450 at risk EG0018 affected902 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Vulvovaginal injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Biopsy vulva	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Blood glucose increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Body temperature increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
C-reactive protein increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Electrocardiogram abnormal	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Fibrin D dimer increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Haemoglobin decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Lipase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Platelet count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0015 affected902 at risk
Troponin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Weight decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
White blood cell count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0013 affected902 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0014 affected902 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected450 at risk EG00121 affected902 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0016 affected902 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Abdominal wall neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cerebellar tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0007 affected450 at risk EG00115 affected902 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Metastases to large intestine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Metastases to reproductive organ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Metastases to small intestine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Amnesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Asterixis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Coma	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0015 affected902 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0015 affected902 at risk
Hemianopia homonymous	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Myoclonus	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Neuralgia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Sciatica	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0016 affected902 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Device dislocation	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Thrombosis in device	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Conversion disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0013 affected902 at risk
Hallucination	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Mental disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Personality change	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected450 at risk EG0014 affected902 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0017 affected902 at risk
Incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0014 affected902 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0014 affected902 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Urogenital fistula	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vesicocutaneous fistula	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Uterine fistula	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0011 affected902 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vaginal ulceration	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected450 at risk EG00110 affected902 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0012 affected902 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0016 affected902 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0013 affected902 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected450 at risk EG00111 affected902 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Urticarial vasculitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Catheter placement	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Chemotherapy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0011 affected902 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Cytoreductive surgery	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0010 affected902 at risk
Ileostomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Intestinal resection	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Laparotomy	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Large intestine anastomosis	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vaginal operation	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Accelerated hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Circulatory collapse	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected450 at risk EG0014 affected902 at risk
Haematoma	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0015 affected902 at risk
Hypertensive crisis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0014 affected902 at risk
Lymphocele	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected450 at risk EG0016 affected902 at risk
Lymphoedema	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Malignant hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Thrombophlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0016 affected902 at risk
Varicose vein	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Vasculitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0011 affected902 at risk
Venous occlusion	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected450 at risk EG0010 affected902 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected450 at risk EG0012 affected902 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG000129 affected450 at risk EG001317 affected902 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00078 affected450 at risk EG001165 affected902 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG000203 affected450 at risk EG001419 affected902 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00087 affected450 at risk EG001301 affected902 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected450 at risk EG00155 affected902 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000111 affected450 at risk EG001281 affected902 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00058 affected450 at risk EG001125 affected902 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000151 affected450 at risk EG001254 affected902 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000114 affected450 at risk EG001692 affected902 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00024 affected450 at risk EG00177 affected902 at risk
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0009 affected450 at risk EG00153 affected902 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000231 affected450 at risk EG001583 affected902 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00024 affected450 at risk EG00151 affected902 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000119 affected450 at risk EG001391 affected902 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG00065 affected450 at risk EG001163 affected902 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG000201 affected450 at risk EG001388 affected902 at risk
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG00030 affected450 at risk EG00162 affected902 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG00047 affected450 at risk EG00148 affected902 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG00027 affected450 at risk EG00135 affected902 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG00046 affected450 at risk EG00164 affected902 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG00021 affected450 at risk EG00158 affected902 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG00032 affected450 at risk EG00153 affected902 at risk
Cystitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00017 affected450 at risk EG00166 affected902 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00036 affected450 at risk EG00173 affected902 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00050 affected450 at risk EG001131 affected902 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00049 affected450 at risk EG001259 affected902 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00041 affected450 at risk EG001219 affected902 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00016 affected450 at risk EG00174 affected902 at risk
Haemoglobin decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00024 affected450 at risk EG00156 affected902 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00023 affected450 at risk EG00174 affected902 at risk
Platelet count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00017 affected450 at risk EG00163 affected902 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00063 affected450 at risk EG001168 affected902 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00025 affected450 at risk EG00185 affected902 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00025 affected450 at risk EG00192 affected902 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG000137 affected450 at risk EG001242 affected902 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00054 affected450 at risk EG00183 affected902 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected450 at risk EG00162 affected902 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00029 affected450 at risk EG00156 affected902 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG000107 affected450 at risk EG001201 affected902 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00056 affected450 at risk EG00195 affected902 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00036 affected450 at risk EG00177 affected902 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00037 affected450 at risk EG001126 affected902 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00053 affected450 at risk EG001140 affected902 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00085 affected450 at risk EG001172 affected902 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00064 affected450 at risk EG001100 affected902 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG000114 affected450 at risk EG001214 affected902 at risk
Polyneuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00025 affected450 at risk EG00150 affected902 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00027 affected450 at risk EG00136 affected902 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00032 affected450 at risk EG00151 affected902 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00057 affected450 at risk EG001105 affected902 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00034 affected450 at risk EG00157 affected902 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00055 affected450 at risk EG001109 affected902 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected450 at risk EG00172 affected902 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG000278 affected450 at risk EG001519 affected902 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00032 affected450 at risk EG00144 affected902 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00050 affected450 at risk EG00195 affected902 at risk
Hot flush	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00045 affected450 at risk EG00173 affected902 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00023 affected450 at risk EG001119 affected902 at risk

ID	Term
D010051	Ovarian Neoplasms
D010534	Peritoneal Neoplasms

Ancestor Terms

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
D000008	Abdominal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D010532	Peritoneal Diseases

ID	Term
D017239	Paclitaxel
C530716	nintedanib
D016190	Carboplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes