Phase 2b Study of Cetuximab With Platinum-Based Chemo as... | NCT00828841

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paclitaxel, Carboplatin, Cetuximab (Arm A)	Active Comparator	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.	Drug: Cetuximab Drug: Paclitaxel Drug: Carboplatin
Platinum, Gemcitabine, Cetuximab (Arm B)	Active Comparator	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.	Drug: Cetuximab Drug: Carboplatin Drug: Gemcitabine Drug: Cisplatin
Platinum, Pemetrexed, Cetuximab (Arm C)	Active Comparator	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.

Measure	Description	Time Frame
Overall Survival by Treatment Arm		Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Measure	Description	Time Frame
1-year Survival by Treatment Arm		Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Overall Survival by Histology

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent before study-related activities
Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease
Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)
Male or female ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
Serum creatinine ≤ 1.25 x ULN
Recovery from prior surgery or radiation to Grade 1 or better toxicity
Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
Women who are pregnant or breastfeeding
Women with a positive pregnancy test during screening or prior to study drug administration
Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization
Treatment with any investigational agent(s) within 4 weeks prior to study entry
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
Carcinoid, atypical carcinoid or small cell lung cancer
Symptomatic or uncontrolled mets in the central nervous system
Prior invasive malignancy requiring ongoing therapy within the past year
Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV
Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
Known allergic/hypersensitivity reaction to any of the components of study treatments
Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0
History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Name	Affiliation	Role
Lee Schwartzberg, MD, FACP	Accelerated Community Oncology Research Network	Study Chair

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
BG001	Platinum, Gemcitabine, Cetuximab (Arm B)	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
BG002	Platinum, Pemetrexed, Cetuximab (Arm C)	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
BG003	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

Overall Survival by Treatment Arm

Two subjects in Arm A were censored due to negative event intervals.

Posted

Median

95% Confidence Interval

Months

Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

ID	Title	Description
OG000	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
OG001	Platinum, Gemcitabine, Cetuximab (Arm B)	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
OG002	Platinum, Pemetrexed, Cetuximab (Arm C)	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.

Units	Counts
Participants	OG000233 OG001236 OG002130

Title

Denominators

Categories

Title	Measurements
	OG0009.5(8.3 to 11.4) OG0018.3(7.1 to 9.9) OG00210.6(8.0 to 14.5)

Secondary

1-year Survival by Treatment Arm

Posted

Number

95% Confidence Interval

percentage of participants

ID	Title	Description
OG000	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
OG001	Platinum, Gemcitabine, Cetuximab (Arm B)	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.

Secondary

Overall Survival by Histology

Subjects were stratified by histology prior to randomization to a treatment arm.

Posted

Median

95% Confidence Interval

Months

ID	Title	Description
OG000	Squamous Cell Histology	Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
OG001	Non-squamous Cell Histology	Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	109	235	221	235
EG001	Platinum, Gemcitabine, Cetuximab (Arm B)	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	128	236	215	236
EG002	Platinum, Pemetrexed, Cetuximab (Arm C)	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	68	130	119	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0015 affected236 at risk EG0021 affected130 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Accidental Exposure	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Adverse Reation	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0016 affected236 at risk EG0020 affected130 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG00119 affected236 at risk EG0026 affected130 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Arterial Thrombosis	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Asthenia	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Atrial Flutter	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Bacteremia	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blood Creatinine Increased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blood/Bone Marrow Hemoglobin	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Brain Edema	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bronchial Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bronchopneumonia	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Catheter Site Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Central Nervous System Hemorrhage	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Central Pain Syndrome	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Cerebellar Infarction	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cerebral Ischemia	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Chest Pain	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0006 affected235 at risk EG0015 affected236 at risk EG0021 affected130 at risk
Chills	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Clostridial Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Colitis	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Confusional State	Psychiatric disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Cytokine Release Syndrome	Immune system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Death	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0005 affected235 at risk EG0013 affected236 at risk EG0022 affected130 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0019 affected236 at risk EG0021 affected130 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0009 affected235 at risk EG0018 affected236 at risk EG0027 affected130 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Disease Progression	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0005 affected235 at risk EG0017 affected236 at risk EG0026 affected130 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0005 affected235 at risk EG00110 affected236 at risk EG0026 affected130 at risk
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dysuria	Renal and urinary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Eastern Cooperative Oncology Group Performance Status	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Ejection Fraction Decreased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Enterocutaneous Fistula	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Esophageal Pain	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Fatigue	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0006 affected235 at risk EG0014 affected236 at risk EG0022 affected130 at risk
Fungemia	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Gastric Ulcer Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Gastric Volvulus	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0022 affected130 at risk
General Physical Health Deterioration	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Generalized Edema	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hematuria	Renal and urinary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hemiparesis	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hemoglobin	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hypercalcemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hypersensitivity	Immune system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0015 affected236 at risk EG0022 affected130 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Infectious Pleural Effusion	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0008 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Large Cell Carcinoma Of The Respiratory Tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Leg Amputation	Surgical and medical procedures	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Lipase Increased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lung Infection	Immune system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Medication Error	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Metastases To Bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Multi-Organ Failure	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Myocardial Ischemia	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0024 affected130 at risk
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0006 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Neutrophil Count	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Neutrophil Count Decreased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Non-Small Cell Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pain	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0015 affected236 at risk EG0021 affected130 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0022 affected130 at risk
Pericardial Effusion Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Peripheral Edema	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Platelet Count Decreased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0004 affected235 at risk EG0019 affected236 at risk EG0025 affected130 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pneumonia	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG00015 affected235 at risk EG0019 affected236 at risk EG0022 affected130 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0005 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Pneumothorax Traumatic	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG00010 affected235 at risk EG00114 affected236 at risk EG0023 affected130 at risk
Pulmonary Hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pyrexia	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Radiation Pneumonitis	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Recall Phenomenon	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Rectal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Renal Failure	Renal and urinary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0005 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Restrictive Cardiomyopathy	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0024 affected130 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Spinal Pain	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Splenic Hematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Subdural Hematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Superior Vena Cava Syndrome	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0023 affected130 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG00115 affected236 at risk EG0023 affected130 at risk
Thrombophlebitis	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Thrombosis	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Transaminases Increased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Transient Ischemic Attack	Nervous system disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Troponin Increased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Tumor Embolism	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Ulcer Hemorrhage	General disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Ulcerative Keratitis	Eye disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Upper Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Urinart Tract Infection	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Urosepsis	Infections and infestations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Vasculitis	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Venous Valve Ruptured	Vascular disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Ventricular Dysfunction	Cardiac disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Volvulus	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Non-systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0023 affected130 at risk
White Blood Cell Count	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
White Blood Cell Increased	Investigations	MedDRA (15.0)	Non-systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
7th Nerve Paralysis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0022 affected130 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00019 affected235 at risk EG00118 affected236 at risk EG0027 affected130 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0015 affected236 at risk EG0021 affected130 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0024 affected130 at risk
Abnormal Dreams	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Abscess Drainage	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Abscess Neck	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Adrenal Mass	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Adverse Drug Reaction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Agitation	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0022 affected130 at risk
Alanine Aminotransferase	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0023 affected130 at risk
Alanine Aminotransferase Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00010 affected235 at risk EG0017 affected236 at risk EG0027 affected130 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00053 affected235 at risk EG00127 affected236 at risk EG0026 affected130 at risk
Amylase Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Anal Fissure	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00083 affected235 at risk EG001105 affected236 at risk EG00252 affected130 at risk
Angina Pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Anhidrosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Anuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Anxiety	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected235 at risk EG00117 affected236 at risk EG0029 affected130 at risk
Aortic Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Arteriosclerosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00031 affected235 at risk EG00115 affected236 at risk EG0024 affected130 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Ascites	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Aspartate Aminotransferase	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0008 affected235 at risk EG00110 affected236 at risk EG0027 affected130 at risk
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG00024 affected235 at risk EG00113 affected236 at risk EG0029 affected130 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Ataxia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Atrial Septal Defect Repair	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00024 affected235 at risk EG00125 affected236 at risk EG00221 affected130 at risk
Bacterial Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Balance Disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Biopsy Endometrium	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bladder Pain	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blepharitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blepharospasm	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blindness	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Albumin	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Blood Albumin Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Blood Alkaline Phosphatase	Investigations	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0024 affected130 at risk
Blood Alkaline Phosphatase Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00018 affected235 at risk EG00114 affected236 at risk EG0026 affected130 at risk
Blood Bicarbonate Abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Bicarbonate Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Bilirubin Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Bilirubin Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Blood Calcium Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Blood Chloride Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blood Cholesterol Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Blood Creatinine	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0023 affected130 at risk
Blood Creatinine Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blood Creatinine Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0014 affected236 at risk EG0023 affected130 at risk
Blood Electrolytes Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Glucose	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Blood Glucose Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Blood Glucose Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Magnesium	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Blood Magnesium Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00018 affected235 at risk EG00110 affected236 at risk EG0029 affected130 at risk
Blood Phosphorus Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Potassium	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Blood Potassium Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0015 affected236 at risk EG0021 affected130 at risk
Blood Potassium Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Pressure Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Pressure Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Sodium	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Sodium Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Blood Sodium Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood Urea Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Blood Urea Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Blood Uric Acid Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Blood/Bone Marrow Hemoglobin	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected235 at risk EG0017 affected236 at risk EG0023 affected130 at risk
Breast Mass	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Breast Pain	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Breath Sounds Abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0015 affected236 at risk EG0022 affected130 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Burning Sensation	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0026 affected130 at risk
Carbuncle	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cardiac Valve Disease	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cataract	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Catheter Placement	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Catheter Site Discharge	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Catheter Site Erythema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Catheter Site Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Catheter Site Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0023 affected130 at risk
Central Nervous System Hemorrhage	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Central Venous Catheterization	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cerumen Impaction	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Cheilitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Chemical Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Chest Discomfort	General disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Chest Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG00013 affected235 at risk EG00118 affected236 at risk EG00210 affected130 at risk
Chest Wall Cyst	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Chest X-Ray Abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Chills	General disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG00114 affected236 at risk EG0024 affected130 at risk
Cholelithotomy	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Coagulation Factor Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cognitive Disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Colony Stimulating Factor Therapy	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Confusional State	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00014 affected235 at risk EG0017 affected236 at risk EG0024 affected130 at risk
Conjunctival Hemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Conjunctivitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0013 affected236 at risk EG0025 affected130 at risk
Conjunctivitis Infective	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00079 affected235 at risk EG00175 affected236 at risk EG00239 affected130 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0014 affected236 at risk EG0024 affected130 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00041 affected235 at risk EG00152 affected236 at risk EG00222 affected130 at risk
Cushingoid	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cyst	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Cystitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Dark Circles Under Eyes	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Deafness	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00074 affected235 at risk EG00163 affected236 at risk EG00244 affected130 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0022 affected130 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00029 affected235 at risk EG00119 affected236 at risk EG00212 affected130 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected235 at risk EG00111 affected236 at risk EG0029 affected130 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0011 affected236 at risk EG0024 affected130 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00068 affected235 at risk EG00155 affected236 at risk EG00232 affected130 at risk
Device Infusion Issue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Device Malfunction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Device Occlusion	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Device Related Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00070 affected235 at risk EG00147 affected236 at risk EG00225 affected130 at risk
Diplopia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Disease Progression	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00026 affected235 at risk EG00132 affected236 at risk EG00222 affected130 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Drug Hypersensitivity	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dry Eye	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0014 affected236 at risk EG0023 affected130 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00027 affected235 at risk EG00131 affected236 at risk EG00213 affected130 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dysfunctional Uterine Bleeding	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dysgeusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00021 affected235 at risk EG00124 affected236 at risk EG0023 affected130 at risk
Dyskinesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00014 affected235 at risk EG00111 affected236 at risk EG0028 affected130 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0018 affected236 at risk EG00211 affected130 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00062 affected235 at risk EG00174 affected236 at risk EG00236 affected130 at risk
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected235 at risk EG00113 affected236 at risk EG0026 affected130 at risk
Dysuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0017 affected236 at risk EG0022 affected130 at risk
Ear Discomfort	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Ear Disorder	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Ear Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Early Satiety	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Eastern Cooperative Oncology Group Performance Status	Investigations	MedDRA (15.0)	Systematic Assessment	EG00044 affected235 at risk EG00139 affected236 at risk EG00231 affected130 at risk
Eastern Cooperative Oncology Group Performance Status Worsened	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Edema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0012 affected236 at risk EG0024 affected130 at risk
Effusion	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Ejection Fraction Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Embolism	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00028 affected235 at risk EG00133 affected236 at risk EG00216 affected130 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0025 affected130 at risk
Esophageal Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Esophagitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Euphoric Mood	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Exfoliative Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0012 affected236 at risk EG0024 affected130 at risk
Extravasation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Eye Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Eye Inflammation	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Eye Irritation	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Eye Pruritus	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Eye Ptosis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Eye Swelling	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Face Edema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Facial Paresis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG000131 affected235 at risk EG001131 affected236 at risk EG00276 affected130 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Fecal Incontinence	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Feces Discolored	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Feces Hard	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Feeling Hot	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Feeling Jittery	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Flatulence	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0015 affected236 at risk EG0024 affected130 at risk
Flushing	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0017 affected236 at risk EG0022 affected130 at risk
Folliculitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Fungal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Fungal Skin Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Furuncle	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Gait Disturbance	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gamma-Glutamyltransferase	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Gastritis Hemorrhagic	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0015 affected236 at risk EG0023 affected130 at risk
Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gastrointestinal Pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
General Physical Health Deterioration	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
General Symptom	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Genital Burning Sensation	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Gingival Pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Glomerular Filtration Rate Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Glossodynia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Glucose Tolerance Impaired	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Gout	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hair Disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hair Growth Abnormal	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Hallucination	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00026 affected235 at risk EG00125 affected236 at risk EG00219 affected130 at risk
Heart Rate Irregular	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hematemesis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hematochezia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hematocrit	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hematocrit Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Hematology Test Abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hematoma	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hematuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Hemiparesis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Hemoglobin	Investigations	MedDRA (15.0)	Systematic Assessment	EG00016 affected235 at risk EG00117 affected236 at risk EG00212 affected130 at risk
Hemoglobin Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00011 affected235 at risk EG00121 affected236 at risk EG0027 affected130 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG00113 affected236 at risk EG0024 affected130 at risk
Hemorrhage	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hemorrhage Diathesis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hemorrhoidal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0018 affected236 at risk EG0024 affected130 at risk
Hepatic Enzyme Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hernia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Herpes Zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0015 affected236 at risk EG0020 affected130 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hordeolum	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hot Flush	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0023 affected130 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hyperacusis	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hyperbiliubinemia	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Hypercalcemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0017 affected236 at risk EG0023 affected130 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00023 affected235 at risk EG00115 affected236 at risk EG00216 affected130 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0015 affected236 at risk EG0024 affected130 at risk
Hyperlipidemia	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hypermagnesemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0025 affected130 at risk
Hypernatremia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Hyperreflexia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG00010 affected235 at risk EG0014 affected236 at risk EG0022 affected130 at risk
Hypersensitivity	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hypersomnia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0013 affected236 at risk EG0027 affected130 at risk
Hypertriglyceridemia	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00013 affected235 at risk EG00118 affected236 at risk EG0029 affected130 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00012 affected235 at risk EG00116 affected236 at risk EG00213 affected130 at risk
Hypoesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected235 at risk EG0014 affected236 at risk EG0028 affected130 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0014 affected236 at risk EG0023 affected130 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00034 affected235 at risk EG00124 affected236 at risk EG00222 affected130 at risk
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00080 affected235 at risk EG00164 affected236 at risk EG00237 affected130 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected235 at risk EG00118 affected236 at risk EG00216 affected130 at risk
Hypophosphatemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG00029 affected235 at risk EG00114 affected236 at risk EG00210 affected130 at risk
Hypothermia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Hypothyroidism	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Hypovolemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0014 affected236 at risk EG0023 affected130 at risk
Implant Site Scar	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Incontinence	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Increased Upper Airway Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Inflammatory Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Influenza	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Influenza Like Illness	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG00012 affected235 at risk EG00113 affected236 at risk EG0024 affected130 at risk
Infusion Site Extravasation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Injection Site Reaction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Inner Ear Disorder	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00031 affected235 at risk EG00132 affected236 at risk EG00216 affected130 at risk
Intermittent Claudication	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
International Normalized Ratio Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
International Normalized Ratio Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Intervertebral Disc Protusion	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Intestinal Mass	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Iron Deficiency Anemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Ischemia	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Jugular Vein Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Kawasaki's Disease	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Keratitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0022 affected130 at risk
Lacrimation Increased	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0018 affected236 at risk EG0028 affected130 at risk
Lactic Acidosis	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Laryngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00020 affected235 at risk EG00120 affected236 at risk EG00213 affected130 at risk
Limb Discomfort	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Lip Dry	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lip Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lip Ulceration	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Local Swelling	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Localized Edema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Localized Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0016 affected236 at risk EG0021 affected130 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Lung Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Lyme Disease	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Lymphatic Disorder	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Lymphedema	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Lymphocyte Count	Investigations	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Lymphocyte Count Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00019 affected235 at risk EG00118 affected236 at risk EG00220 affected130 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Magnesium Metabolism Disorder	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Major Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Malaise	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Mass	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Mastoiditis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Medical Device Change	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Memory Impairment	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Metabolic Function Test	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Metastatic Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Micturition Urgency	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Migraine	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Mood Altered	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Mouth Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Mucosal Inflammation	General disorders	MedDRA (15.0)	Systematic Assessment	EG00025 affected235 at risk EG00112 affected236 at risk EG00221 affected130 at risk
Muscle Contractions Involuntary	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG00112 affected236 at risk EG00213 affected130 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG00111 affected236 at risk EG0029 affected130 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Musculoskeletal Disorder	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00015 affected235 at risk EG0019 affected236 at risk EG0023 affected130 at risk
Myalgia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00016 affected235 at risk EG0015 affected236 at risk EG0023 affected130 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Nail Bed Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Nail Bed Inflammation	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Nail Discoloration	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Nail Disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected235 at risk EG0015 affected236 at risk EG0022 affected130 at risk
Nail Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Nail Operation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Nasal Discharge Discoloration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Nasal Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Nasal Dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Nasopharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00098 affected235 at risk EG00184 affected236 at risk EG00261 affected130 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0015 affected236 at risk EG0024 affected130 at risk
Nervousness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00054 affected235 at risk EG00111 affected236 at risk EG0024 affected130 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00079 affected235 at risk EG00191 affected236 at risk EG00242 affected130 at risk
Neutrophil Count	Investigations	MedDRA (15.0)	Systematic Assessment	EG00014 affected235 at risk EG00117 affected236 at risk EG00210 affected130 at risk
Neutrophil Count Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00012 affected235 at risk EG00111 affected236 at risk EG0022 affected130 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0023 affected130 at risk
Nocturia	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Non-Alcoholic Steatohepatitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Occult Blood Positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Onychomycosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Optic Nerve Sheath Hemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Oral Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0015 affected236 at risk EG0023 affected130 at risk
Oral Discomfort	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Oral Herpes	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Oral Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Oral Mucosal Erythema	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Oral Pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0023 affected130 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Otitis Externa	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Otitis Media	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Oxygen Saturation Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG00023 affected235 at risk EG00116 affected236 at risk EG0025 affected130 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00025 affected235 at risk EG00116 affected236 at risk EG00210 affected130 at risk
Pain Of Skin	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Painful Respiration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pallor	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Palmar-Plantar Erythrodysesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0013 affected236 at risk EG0023 affected130 at risk
Palpitations	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0024 affected130 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG00110 affected236 at risk EG0023 affected130 at risk
Paranasal Sinus Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Paranasal Sinus Hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Paresthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0012 affected236 at risk EG0028 affected130 at risk
Paresthesia Oral	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Paronychia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00011 affected235 at risk EG0013 affected236 at risk EG0027 affected130 at risk
Parotitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Penile Swelling	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Penile Ulceration	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Performance Status Decreased	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Perianal Erythema	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Perineal Abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Periorbital Edema	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Peripheral Edema	General disorders	MedDRA (15.0)	Systematic Assessment	EG00026 affected235 at risk EG00134 affected236 at risk EG00212 affected130 at risk
Peripheral Embolism	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Peripheral Sensorimotor Neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00036 affected235 at risk EG0016 affected236 at risk EG0024 affected130 at risk
Peroneal Nerve Palsy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Personality Change	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0018 affected236 at risk EG0021 affected130 at risk
Phantom Pain	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Pharyngitis Bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Phlebitis Superficial	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Photopsia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Platelet Count	Investigations	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG00115 affected236 at risk EG0028 affected130 at risk
Platelet Count Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG00122 affected236 at risk EG0027 affected130 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0015 affected236 at risk EG0024 affected130 at risk
Pleural Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0013 affected236 at risk EG0021 affected130 at risk
Pleurodesis	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG0013 affected236 at risk EG0026 affected130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0023 affected130 at risk
Polyuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Post Herpetic Neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Presyncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected235 at risk EG0016 affected236 at risk EG0023 affected130 at risk
Protein Total Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Proteinuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected235 at risk EG00122 affected236 at risk EG0022 affected130 at risk
Pruritus Generalized	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Pulmonary Hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG00023 affected235 at risk EG00123 affected236 at risk EG00210 affected130 at risk
Radiation Mucositis	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Radiation Skin Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00088 affected235 at risk EG001100 affected236 at risk EG00251 affected130 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Raynaud's Phenomenon	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Recall Phenomenon	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Rectal Hemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0014 affected236 at risk EG0022 affected130 at risk
Red Blood Cell Count Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Reflux Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Renal Failure	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Renal Impairment	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Restlessness	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Retching	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Retinal Vein Occlusion	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Rhinitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00010 affected235 at risk EG0016 affected236 at risk EG0025 affected130 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Saliva Altered	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Salivary Hypersecretion	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Scrotal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Sensation of Pressure	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Sensory Loss	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Sinus Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Sinus Operation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0013 affected236 at risk EG0020 affected130 at risk
Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Atrophy	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Candida	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Skin Depigmentation	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Discoloration	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0010 affected236 at risk EG0023 affected130 at risk
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Skin Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Skin Lesion Excision	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Sleep Disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Slow Speech	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Soft Tissue Inflammation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Somnolence	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Sputum Discolored	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Staphylococcal Bacteremia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Staphylococcus Test Positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00024 affected235 at risk EG00120 affected236 at risk EG00214 affected130 at risk
Stool Ph Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Subcutaneous Abscess	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Subdural Hematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Swelling	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0022 affected130 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected235 at risk EG0014 affected236 at risk EG0022 affected130 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG00111 affected236 at risk EG0023 affected130 at risk
Tearfulness	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Temperature Intolerance	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Tenderness	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Tension Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Therapy Regimen Changed	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Thirst	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00061 affected235 at risk EG001122 affected236 at risk EG00249 affected130 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Thrombophlebitis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Tinea Cruris	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Tinea Pedis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0016 affected236 at risk EG0022 affected130 at risk
Tongue Disorder	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Tooth Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Toothache	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Transaminases Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Tremor	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG00111 affected236 at risk EG0024 affected130 at risk
Trichomegaly	Congenital, familial and genetic disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Trigeminal Neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Troponin I Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Upper Aerodigestive Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Upper Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0016 affected236 at risk EG0024 affected130 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0012 affected236 at risk EG0021 affected130 at risk
Urinary Bladder Hemorrhage	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0009 affected235 at risk EG0019 affected236 at risk EG0027 affected130 at risk
Urine Color Abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Urine Flow Decreased	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Urine Output Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Vaginal Hemorrhage	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0022 affected130 at risk
Vaginal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Venous Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Venous Insufficiency	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0014 affected236 at risk EG0021 affected130 at risk
Viral Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Vision Blurred	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected235 at risk EG0017 affected236 at risk EG0023 affected130 at risk
Visual Impairment	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0012 affected236 at risk EG0023 affected130 at risk
Vitamin B12 Deficiency	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00041 affected235 at risk EG00147 affected236 at risk EG00227 affected130 at risk
Vulvitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Vulvovaginal Erythema	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0012 affected236 at risk EG0020 affected130 at risk
Weight	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
Weight Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG000119 affected235 at risk EG001100 affected236 at risk EG00256 affected130 at risk
Weight Fluctuation	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0015 affected236 at risk EG0022 affected130 at risk
Weight Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00026 affected235 at risk EG00123 affected236 at risk EG00213 affected130 at risk
Weight Normal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected235 at risk EG0010 affected236 at risk EG0020 affected130 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected235 at risk EG0016 affected236 at risk EG0023 affected130 at risk
White Blood Cell Count	Investigations	MedDRA (15.0)	Systematic Assessment	EG00014 affected235 at risk EG00116 affected236 at risk EG00216 affected130 at risk
White Blood Cell Count Decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected235 at risk EG0016 affected236 at risk EG0020 affected130 at risk
White Blood Cell Count Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0021 affected130 at risk
White Blood Cell Disorder	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected235 at risk EG0014 affected236 at risk EG0020 affected130 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Xerophthalmia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Xerosis	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0010 affected236 at risk EG0021 affected130 at risk
Tobacco User	Social circumstances	MedDRA (15.0)	Systematic Assessment	EG0000 affected235 at risk EG0011 affected236 at risk EG0020 affected130 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Anniston	Alabama		United States

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Term
D000068818	Cetuximab
D017239	Paclitaxel
D016190	Carboplatin
D000093542	Gemcitabine
D002945	Cisplatin