Safety, Tolerability, and Immunoregulatory Activity of Mo... | NCT02281409

Name	Class
Kyowa Hakko Kirin Pharma, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Phase I: Mogamulizumab (KW-0761)	Experimental	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin.	Biological: Mogamulizumab (KW-0761)
Phase II: Mogamulizumab (KW-0761)	Experimental	Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial).	Biological: Mogamulizumab (KW-0761)

Name	Type	Description	Arm Group Labels	Other Names
Mogamulizumab (KW-0761)	Biological		Phase I: Mogamulizumab (KW-0761) Phase II: Mogamulizumab (KW-0761)

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD)	A standard 3+3 design will be utilized to determine the MTD. Four dose levels of KW-0761 will be investigated (0.5mg/kg, 1mg/kg, 3mg/kg, 10mg/kg). Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.	1 year

Measure	Description	Time Frame
Overall Response	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent form signed by the subject.
Males and females 18 years or older at the time of dose initiation.
Histologically confirmed unresectable solid tumor malignancy with at least 1 measurable lesion. In the expansion phase, eligibility will be limited to metastatic triple negative breast cancer that has received prior taxane and anthracycline therapy; Metastatic NSCLC that is not ALK+ and does not have a EGFR sensitizing mutation; and metastatic gastric cancer
Previously treated for an advanced cancer and there are no curative therapy options available
Karnofsky Performance Status ≥70 in the 30 day baseline period immediately prior to dosing.
Evidence of adequate organ function by standard laboratory tests:
- Serum creatinine (Cr) ≤1.5 X upper limit of normal (ULN)
- Serum total and (T -Bil ) ≤1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
- Platelets (Plts) ≥ 100,000/μl
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥1000/mm3
All female subjects of childbearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Examples of adequate methods of contraception include abstinence, intrauterine device, hormonal contraception, use of spermicide and a condom by sexual partner, or partner with a vasectomy. Adequate contraception must be used from the beginning of the screening period until at least 16 weeks after the last dose of KW-0761. Male subjects with partners of childbearing potential must use a barrier method of contraception from the day of the first dose of KW-0761 until at least 16 weeks after the last dose.
Life expectancy > 12 weeks
Previously treated for advanced cancer with no additional therapy options available known to prolong survival.

Exclusion Criteria:

Evidence of clinically significant of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing.

History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis.

A history of any major surgery within 6 weeks prior to dosing.
Any history of systemic anticancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpoints.
Any concomitant serious physical illness other than cancer (i.e., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing.
Any history of Stevens-Johnson syndrome.
Clinically significant heart disease, defined as NYHA Class III or IV.
Any allergic reaction to a previously administered monoclonal antibody or other therapeutic protein.
Any significant systemic infection within 4 weeks prior to dosing.
Pregnancy or breast-feeding.
An existing diagnosis of HIV, hepatitis B, hepatitis C, or any current laboratory findings or clinical signs and symptoms that suggest these conditions.
Subjects with active herpes simplex or herpes zoster. Subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study.
Unresolved immune- related adverse events following prior biological therapy
Use of any investigational drugs within 30 days prior to dosing.
Any condition that requires or is likely to require treatment with systemic corticosteroids within the Core Study Period and short term follow-up.
Subjects that have had a myocardial infarction within the last 6 months.
Subjects on any immunomodulatory drug.

Name	Affiliation	Role
Jedd Wolchok, MD, PhD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan Kettering Cancer Center	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 (0.5 mg/kg KW-0761 IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 17, 2016

Arm/Group Information

ID	Title	Description
BG000	Cohort 1 (0.5 mg/kg KW-0761 IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)
BG001	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)
BG002	Cohort 3 (3.0mg/kg KW-0761IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)
BG003	Cohort 4 (10.0mg/kg KW-0761IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0025 BG0036 BG00417

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

Maximum Tolerated Dose (MTD)

A standard 3+3 design will be utilized to determine the MTD. Four dose levels of KW-0761 will be investigated (0.5mg/kg, 1mg/kg, 3mg/kg, 10mg/kg). Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.

Posted

Number

mg/kg KW-0761IV

1 year

ID	Title	Description
OG000	Mogamulizumab (KW-0761)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)

Units	Counts
Participants	OG00022

Title

Denominators

Categories

Title	Measurements
	OG00010.0

Secondary

Overall Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Cohort 1 (0.5 mg/kg KW-0761 IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)
OG001	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (0.5 mg/kg KW-0761 IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)	3	3	2	3	3	3
EG001	Cohort 2 (1.0 mg/kg KW-0761IV) Q2W	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)	3	3	2	3	3	3
EG002	Cohort 3 (3.0mg/kg KW-0761IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)	5	5	2	5	5	5
EG003	Cohort 4 (10.0mg/kg KW-0761IV)	Patients will be enrolled to receive a weekly intravenous (IV) dose of KW-0761 ranging from 0.5 mg/kg to 10.0 mg/kg as feasible starting on Day 1 for 4 weeks. In the absence of toxicity or progression of disease, patients may continue receiving KW-0761 for up to 12 months. Subsequent treatment courses will consist of an infusion every other week. Following end of treatment or treatment completion date, a 24-week short term follow-up (STFU) period of observation will begin. Phase II of the study will enroll a total of 48 subjects, 16 patients in 3 tumor-specific expansion cohorts each treated at the RP2D (MTD, or highest dose tested in Phase I part of trial). Mogamulizumab (KW-0761)	6	6	2	6	6	6

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG0032 affected6 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Lung infection	Infections and infestations	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Nervous system disorders - Other, specify	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Pleural hemorrhage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Rectal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 affected3 at risk EG0012 affected3 at risk EG0024 affected5 at risk EG0033 affected6 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0003 affected3 at risk EG0013 affected3 at risk EG0023 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
White blood cell decreased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0020 affected5 at risk EG003
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected5 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0022 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Blood bilirubin increased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected5 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0003 affected3 at risk EG0011 affected3 at risk EG0021 affected5 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0024 affected5 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Skin & subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected5 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Creatinine increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Fever	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Fibrinogen decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0022 affected5 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected5 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0022 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
INR increased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Lipase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Lung infection	Infections and infestations	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Nail infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Pain	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0021 affected5 at risk EG003
Pleural hemorrhage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Rectal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Serum amylase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003
Skin infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected5 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected5 at risk EG003