Dose/ Schedule Finding Trial of Romiplostim for Chemother... | NCT00413283

NCT00413283

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Drug: Placebo Drug: Gemcitabine Drug: Carboplatin Drug: Cisplatin
Romiplostim 250 μg	Experimental	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Biological: Romiplostim Drug: Gemcitabine Drug: Carboplatin Drug: Cisplatin
Romiplostim 500 μg	Experimental	Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	Biological: Romiplostim Drug: Gemcitabine Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim	Biological	Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.	Romiplostim 250 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.	4 months

Secondary Outcomes

Measure	Description	Time Frame
Duration of Grade 3 or 4 Thrombocytopenia	The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.	3 weeks
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
Life expectancy ≥ 12 weeks at the time of screening
Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the patient must be dose delayed for platelet recovery
Ability to receive the same dose and schedule of chemotherapy during the first on-study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count ≥ 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of screening
Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert's Syndrome)
Adequate renal function; serum creatinine < 1.5 x ULN

Exclusion Criteria:

Receipt of > 1 prior systemic chemotherapy regimen
Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic] thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic uremic syndrome [HUS]) that may exacerbate thrombocytopenia
History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
Use of any nitrosourea or mitomycin-C within 6 weeks of screening
Have received any thrombopoietic growth factor or related substance
Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
Have received any experimental therapy within 4 weeks prior to screening
Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
Known hypersensitivity to any recombinant E. coli-derived product.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Glendale	Arizona	85304	United States
Research Site

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
BG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
BG002	Romiplostim 500 µg	Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
BG003	Romiplostim 750 µg	Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events

This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.

Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG002	Romiplostim 500 µg	Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG003	Romiplostim 750 µg	Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Units	Counts
Participants	OG00012 OG00116 OG00218 OG003

Title

Denominators

Categories

Title	Measurements
	OG00012 OG00116 OG00218 OG003

Secondary

Duration of Grade 3 or 4 Thrombocytopenia

The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.

Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).

Posted

Mean

Standard Deviation

days

3 weeks

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Secondary

Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.

Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Posted

Number

Participants

3 weeks

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Secondary

Number of Participants With Platelet Transfusions

Number of participants who were administered platelet transfusions during first on study treatment cycle.

Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Posted

Number

Participants

3 weeks

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG002	Romiplostim 500 µg

Secondary

Platelet Count on Day 22

Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group

Efficacy Analysis Set, composed of all randomized participants except those who were replaced

Posted

Mean

Standard Deviation

10^9/L

Day 22

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG002	Romiplostim 500 µg

Secondary

Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle

Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.

Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Posted

Number

Participants

8 days

ID	Title	Description
OG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
OG002	Romiplostim 500 µg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	1	12	12	12
EG001	Romiplostim 250 µg	Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	7	16	16	16
EG002	Romiplostim 500 µg	Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	5	18	17	18
EG003	Romiplostim 750 µg	Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.	5	16	14	16

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0013 affected16 at risk EG0021 affected18 at risk EG0031 affected16 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0014 affected16 at risk EG0020 affected18 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Cyanosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Retinal artery occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Catheter related infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Blood creatinine increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0022 affected18 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected12 at risk EG0017 affected16 at risk EG0027 affected18 at risk EG0035 affected16 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected16 at risk EG0022 affected18 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected12 at risk EG0014 affected16 at risk EG0024 affected18 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected12 at risk EG0013 affected16 at risk EG0023 affected18 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected12 at risk EG0018 affected16 at risk EG0028 affected18 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Palpitations	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Ear disorder	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Vision blurred	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected16 at risk EG0022 affected18 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected16 at risk EG0021 affected18 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0014 affected16 at risk EG0025 affected18 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected12 at risk EG0014 affected16 at risk EG0021 affected18 at risk EG003
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Catheter site pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Catheter site swelling	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Chest discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Face oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0015 affected16 at risk EG0024 affected18 at risk EG003
Infusion site extravasation	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Local swelling	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Localised oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Oedema peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0015 affected16 at risk EG0022 affected18 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Fungal oesophagitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Furuncle	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0022 affected18 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Laryngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Skin infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Radiation injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Blood potassium decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Blood potassium increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Platelet count increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Weight decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected16 at risk EG0023 affected18 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0022 affected18 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0023 affected18 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0023 affected18 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected16 at risk EG0020 affected18 at risk EG003
Amnesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0014 affected16 at risk EG0021 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected16 at risk EG0021 affected18 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Tremor	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected16 at risk EG0022 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0014 affected16 at risk EG0023 affected18 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0013 affected16 at risk EG0020 affected18 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected16 at risk EG0020 affected18 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0022 affected18 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0020 affected18 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0023 affected18 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected16 at risk EG0020 affected18 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0022 affected18 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Phlebitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0021 affected18 at risk EG003
Phlebitis superficial	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected16 at risk EG0021 affected18 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected16 at risk EG0020 affected18 at risk EG003

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D009369	Neoplasms
D013921	Thrombocytopenia

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D056831	Coordination Complexes
D009930	Organic Chemicals
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Term
C488777	romiplostim
D000093542	Gemcitabine
D016190	Carboplatin
D002945	Cisplatin