ACP-196 (Acalabrutinib) in Combination With Pembrolizumab... | NCT02362035

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Acalabrutinib plus Pembrolizumab	Experimental	A nonrandomized study that will be conducted in 2 stages. In the first stage, (Safety), subjects will receive Acalabrutinib Dose A orally administered (PO) twice daily (BID) in combination with Pembrolizumab Dose B administered every 3 weeks (Q3W). The second stage was an expansion of Cohorts with the same dose regimen as the first stage. An additional expansion in subjects with Myelofibrosis was planned but not conducted.	Drug: Acalabrutinib Drug: Pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
Acalabrutinib	Drug	Orally Administered (PO)	Acalabrutinib plus Pembrolizumab

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs)	Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.	104 weeks
Number of Participants With Grade 3-4 Adverse Events	Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03	104 weeks
Number of Participants With Grade 5 Adverse Events	Number of participants with CTCAE Grade 5 (fatal) adverse events	104 weeks
Number of Participants With Any Study-Drug Related AE	Study drug-related AEs were those assessed by investigator as related to study treatment.	104 weeks
Number of Participants With Grade 3-4 Study-Drug Related AE	The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.	104 weeks
Number of Participants With Grade 5 Study-Drug Related AE	Grade 5 (fatal) AEs assessed by investigator as related to study treatment.	104 weeks
Number of Participants With Any SAE	Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Measure	Description	Time Frame
Overall Response Rate	The percentage of subjects who achieve a partial response or complete response	104 weeks
Duration of Response	The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause

Name	Affiliation	Role
AstraZeneca Clinical Study Information Center	1-877-240-9479 - information.center@astrazeneca.com	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona	85704	United States
Research Site

Label	URL
Redacted CSP	View source
Redacted SAP	View source

ID	Title	Description
FG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 18, 2020	Aug 25, 2021

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

Number of Participants With Treatment Emergent Adverse Events (AEs)

Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.

All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000161

Title

Denominators

Categories

Title	Measurements
	OG000160

Primary

Number of Participants With Grade 3-4 Adverse Events

Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With Grade 5 Adverse Events

Number of participants with CTCAE Grade 5 (fatal) adverse events

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With Any Study-Drug Related AE

Study drug-related AEs were those assessed by investigator as related to study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With Grade 3-4 Study-Drug Related AE

The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants

Primary

Number of Participants With Grade 5 Study-Drug Related AE

Grade 5 (fatal) AEs assessed by investigator as related to study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With Any SAE

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts

Primary

Number of Participants With Grade 3-4 Any SAE

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Primary

Number of Participants With Grade 5 Any SAE

Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts

Primary

Number of Participants With Any Study Drug-Related SAE

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Primary

Number of Participants With Any Grade 3-4 Study Drug-Related SAE

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Primary

Number of Participants With Any Grade 5 Study Drug-Related SAE

Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Primary

Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay

AEs that discontinuation of study treatment, or a reduction in dosage, or a delay (temporary withholding) in treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants

Primary

Number of Participants With AE Leading to Study Drug Discontinuation

An adverse event that resulted in the permanent discontinuation of study treatment in the study.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With AE Leading to Study Drug Delay

An adverse event that caused a temporary withholding of study treatment.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Primary

Number of Participants With AE Leading to Study Drug Modification

An adverse event that resulted in a reduction in the dosage of study treatment for that participant.

Posted

Number

Number of participants

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Secondary

Overall Response Rate

The percentage of subjects who achieve a partial response or complete response

Posted

Number

95% Confidence Interval

percent

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Secondary

Duration of Response

The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause

Posted

Median

95% Confidence Interval

Months

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival

The interval from the first dose date of acalabrutinib or pembrolizumab to the earlier of the first documentation of objective disease progression or death from any cause

Posted

Median

95% Confidence Interval

Months

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants

Secondary

Overall Survival

The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause

Posted

Median

95% Confidence Interval

Months

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Secondary

Time to Next Treatment

The time from the first dose date of acalabrutinib or pembrolizumab to the start of the next treatment other than the study treatment

Posted

Median

95% Confidence Interval

Months

104 weeks

ID	Title	Description
OG000	Acalabrutinib + Pembrolizumab	All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Hyperviscosity syndrome	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected161 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Retroperitoneal mass	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Autoimmune disorder	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Abdominal abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Epiglottitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Meningitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected161 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Lymphocyte count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cervical cord compression	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hyponatraemic seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Mental status changes	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00056 events35 affected161 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00027 events16 affected161 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00020 events9 affected161 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0009 events6 affected161 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cardiomegaly	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Extrasystoles	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Myocardial calcification	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Pericarditis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected161 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Deafness	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Borderline glaucoma	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Chalazion	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Dry eye	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Eye pruritus	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Eyelid rash	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lacrimation increased	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Macular degeneration	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Periorbital swelling	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Vision blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Vitreous degeneration	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00017 events11 affected161 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00018 events13 affected161 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00011 events10 affected161 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00021 events20 affected161 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000135 events73 affected161 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected161 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected161 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gingival discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Hyperaesthesia teeth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Melaena	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00063 events43 affected161 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oral pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Palatal disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Proctitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events4 affected161 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00045 events33 affected161 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 events12 affected161 at risk
Axillary pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Catheter site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Chest discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Chills	General disorders	MedDRA 23.0	Systematic Assessment	EG00016 events13 affected161 at risk
Drug withdrawal syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Early satiety	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Exercise tolerance decreased	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Facial pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG00077 events57 affected161 at risk
Feeling cold	General disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Gait disturbance	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Infusion site reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nodule	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected161 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00024 events20 affected161 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 events5 affected161 at risk
Peripheral swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Polyp	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00040 events28 affected161 at risk
Swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Swelling face	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Thirst	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Ulcer	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 events9 affected161 at risk
Candida infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected161 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Ear infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Epiglottitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Eye infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Folliculitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Fungal skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Gingival abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Herpes simplex	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected161 at risk
Histoplasmosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Histoplasmosis disseminated	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Labyrinthitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Localised infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lymphangitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Mucosal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Nasal herpes	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00012 events9 affected161 at risk
Nocardiosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Onychomycosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Oral herpes	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Otitis externa	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Otitis media	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected161 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pyuria	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Rash pustular	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Rhinovirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Root canal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00013 events11 affected161 at risk
Skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected161 at risk
Soft tissue infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tooth abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00040 events26 affected161 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00013 events10 affected161 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00023 events18 affected161 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00015 events10 affected161 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Muscle contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00054 events21 affected161 at risk
Amylase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00029 events18 affected161 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00011 events7 affected161 at risk
Blood immunoglobulin g decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Blood uric acid increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Heart rate irregular	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Immunoglobulins decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Influenza a virus test positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lymphocyte count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0007 events5 affected161 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Oxygen saturation decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00011 events7 affected161 at risk
Protein total decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Serum ferritin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tri-iodothyronine free decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00011 events9 affected161 at risk
Weight increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0006 events4 affected161 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00050 events42 affected161 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00015 events13 affected161 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0007 events4 affected161 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0007 events5 affected161 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0009 events7 affected161 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00025 events16 affected161 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00013 events10 affected161 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00014 events10 affected161 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00025 events19 affected161 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00025 events21 affected161 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected161 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00016 events13 affected161 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00010 events9 affected161 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 events8 affected161 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00013 events12 affected161 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00011 events8 affected161 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Winged scapula	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Ataxia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00037 events32 affected161 at risk
Dizziness postural	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Head discomfort	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00071 events57 affected161 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Migraine	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Neuralgia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00013 events10 affected161 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Parkinsonism	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Presyncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Sciatic nerve neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Sciatica	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Sinus headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Taste disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Agitation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0004 events2 affected161 at risk
Alcoholism	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Confusional state	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected161 at risk
Delirium	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected161 at risk
Dyssomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00021 events20 affected161 at risk
Mental status changes	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Restlessness	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Stress	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nephritis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nocturia	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Polyuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Genital lesion	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00068 events44 affected161 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected161 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00034 events29 affected161 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected161 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected161 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00015 events12 affected161 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected161 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pharyngeal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected161 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected161 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected161 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Tracheal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected161 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected161 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Dandruff	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected161 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events3 affected161 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected161 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected161 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00014 events13 affected161 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0009 events7 affected161 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00015 events14 affected161 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00037 events22 affected161 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events4 affected161 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00010 events9 affected161 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected161 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected161 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Skin sensitisation	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected161 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 events2 affected161 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Aortic stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Flushing	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Hot flush	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected161 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00010 events8 affected161 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00023 events21 affected161 at risk
Lymphoedema	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected161 at risk
Pallor	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk
Vasculitis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected161 at risk

ID	Term
D008224	Lymphoma, Follicular
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D020522	Lymphoma, Mantle-Cell
D008258	Waldenstrom Macroglobulinemia
D009101	Multiple Myeloma
D006689	Hodgkin Disease
D002051	Burkitt Lymphoma
D007943	Leukemia, Hairy Cell

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D006402	Hematologic Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D054219	Neoplasms, Plasma Cell
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D014412	Tumor Virus Infections
D016393	Lymphoma, B-Cell