Study Of CP-751,871 In Patients With Ewing's Sarcoma Fami... | NCT00560235

Label	Type	Description	Intervention Names
1	Experimental		Drug: CP-751,871

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871	Drug	Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity	1

Measure	Description	Time Frame
Objective Response Rate (ORR)	Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.	Baseline and every cycle (4 weeks), for up to 6 cycles

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).	Baseline and every cycle (4 weeks), until progression or death

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Tampa	Florida	33612-9497	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
22025154	Derived	Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Figitumumab Dose Escalation (Phase 1)	Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
FG001

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

Objective Response Rate (ORR)

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.

All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and every cycle (4 weeks), for up to 6 cycles

ID	Title	Description
OG000	Figitumumab 30 mg/kg (Phase 2)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Units	Counts
Participants	OG000106

Title

Denominators

Categories

Title	Measurements
	OG00014.2(8.1 to 22.3)

Secondary

Progression-Free Survival (PFS)

PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).

All enrolled participants with ESFT and who started treatment with figitumumab.

Posted

Median

95% Confidence Interval

months

Baseline and every cycle (4 weeks), until progression or death

ID	Title	Description
OG000	Figitumumab 30 mg/kg (Phase 2)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

All enrolled participants with ESFT and who started treatment with figitumumab.

Posted

Median

95% Confidence Interval

months

Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment

ID	Title	Description
OG000	Figitumumab 30 mg/kg (Phase 2)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax)

The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

milligrams per liter (mg/L)

Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
OG001	Figitumumab 30 mg/kg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
OG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).

Units	Counts
Participants

Secondary

Minimum Observed Plasma Trough Concentration (Cmin)

Cmin is the concentration at the end of treatment cycle (next cycle predose).

The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/L

Cycle 6: predose on Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
OG001	Figitumumab 30 mg/kg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
OG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).

Units	Counts
Participants

Secondary

Plasma Concentration at End of Infusion (Cendinf)

The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/L

Cycle 1 Day 2 and Cycle 5 Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
OG001	Figitumumab 30 mg/kg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
OG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).

Units	Counts
Participants

Secondary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

The dosing interval was 1 cycle (4 weeks) in this study.

The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

milligram*hour per liter (mg*hr/L)

Cycle 5: 1 hour post-infusion on Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
OG001	Figitumumab 30 mg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
OG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).

Units	Counts
Participants

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

mg*hr/L

Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1

ID	Title	Description
OG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
OG001	Figitumumab 30 mg/kg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
OG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).

Units

Secondary

Number of Participants With Positive Anti-Drug Antibody (ADA) Titer

Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.

All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of <6.64.

Posted

Number

participants

Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)

ID	Title	Description
OG000	Figitumumab 30 mg/kg (Phase 2)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Figitumumab 20 mg/kg Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).	2	4	3	4
EG001	Figitumumab 30 mg/kg Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).	3	6	6	6
EG002	Figitumumab 30 mg/kg Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).	10	21	19	21
EG003	Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)	Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.	0	1	1	1
EG004	Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.	3	4	3	4
EG005	Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.	7	9	9	9
EG006	Figitumumab 30mg/kg (Phase 2)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.	47	107	99	107
EG007	Figitumumab 30 mg/kg + Rapamycin (Phase 2)	Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.	16	29	29	29

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG0030 affected1 at risk EG0040 affected4 at risk EG0050 affected9 at risk EG0060 affected107 at risk EG0070 affected29 at risk
Disease progression	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0002 affected4 at risk EG0011 affected6 at risk EG0026 affected21 at risk EG003
Pain	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Acinetobacter infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Bacteraemia	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Sepsis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Chest pain	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
General physical health deterioration	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Medical device complication	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Mucosal inflammation	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pyrexia	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Lung infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haemoglobin decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Convulsion	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Intracranial hypotension	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematoma	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haemorrhage	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG0030 affected1 at risk EG0041 affected4 at risk EG0052 affected9 at risk EG00614 affected107 at risk EG0079 affected29 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Bradycardia	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Conjunctivitis	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Eye movement disorder	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Eye pain	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Eye pruritus	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0025 affected21 at risk EG003
Vision blurred	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected6 at risk EG0025 affected21 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected6 at risk EG0026 affected21 at risk EG003
Retching	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0023 affected21 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected6 at risk EG0028 affected21 at risk EG003
Asthenia	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Catheter site pain	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Chest pain	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0025 affected21 at risk EG003
Fatigue	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected6 at risk EG0024 affected21 at risk EG003
General physical health deterioration	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Impaired healing	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Mucosal inflammation	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pain	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected6 at risk EG0021 affected21 at risk EG003
Pyrexia	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0023 affected21 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0023 affected21 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Lung infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Paronychia	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pneumonia primary atypical	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Sinusitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Wound infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0021 affected21 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Blood creatinine increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Blood sodium decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Breath sounds	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Breath sounds abnormal	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected6 at risk EG0021 affected21 at risk EG003
C-reactive protein increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Haemoglobin decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Neutrophil count decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Weight decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0024 affected21 at risk EG003
Weight increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
White blood cell count increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0022 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0002 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0025 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0021 affected21 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0022 affected21 at risk EG003
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG00210 affected21 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0023 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0024 affected21 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Convulsion	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0024 affected21 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0020 affected21 at risk EG003
Sensory loss	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Somnolence	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Mood altered	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected6 at risk EG0022 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0024 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0022 affected21 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected6 at risk EG0021 affected21 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Scar pain	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Amputation	Surgical and medical procedures	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematoma	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hot flush	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0021 affected21 at risk EG003
Hypotension	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Bone marrow failure	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Bone marrow oedema	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Cerebral palsy	Congenital, familial and genetic disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hearing impaired	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Cushingoid	Endocrine disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dry eye	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Lacrimation increased	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pupils unequal	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Scleral hyperaemia	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Visual impairment	Eye disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gingival recession	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tooth discolouration	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Condition aggravated	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Influenza like illness	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Injection site extravasation	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Malaise	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Medical device complication	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Mucosal dryness	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Mucous membrane disorder	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oedema peripheral	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Swelling	General disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Candidiasis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Conjunctivitis infective	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Device related infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Herpes zoster	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Laryngitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Localised infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Oral herpes	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Otitis media	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Otitis media acute	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Papilloma viral infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pharyngitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Post procedural infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Rhinitis	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Skin infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Viral infection	Infections and infestations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Blood urea increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Blood uric acid increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ejection fraction decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Electrocardiogram ST segment depression	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haemoglobin abnormal	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Right ventricular systolic pressure increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Transaminases increased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
White blood cell count decreased	Investigations	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tetany	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Balance disorder	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Facial paresis	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypotonia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Lethargy	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Memory impairment	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Monoparesis	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Monoplegia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Motor dysfunction	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Neuralgia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Paraparesis	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Paraplegia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Parosmia	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Syncope	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Tremor	Nervous system disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Agitation	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Depression	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Fear	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Micturition disorder	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vesicoureteric reflux	Renal and urinary disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Amenorrhoea	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Perineal erythema	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Scrotal swelling	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Immobile	Social circumstances	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Flushing	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Pallor	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003
Vasodilatation	Vascular disorders	MedDRA version 14.0	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected6 at risk EG0020 affected21 at risk EG003

ID	Title	Description
BG000	Figitumumab Dose Escalation (Phase 1)	Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
BG001	Figitumumab Dose Extension (Phase 1B)	Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
BG002	Figitumumab 30 mg/kg (Phase 2)	Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
BG003	Total	Total of all reporting groups