Cixutumumab in Treating Patients With Relapsed or Refract... | NCT00831844

NCT00831844

ID	Type	Description	Link
NCI-2009-01170	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CDR0000633186	Other Identifier	Clinical Trials.gov
COG-ADVL0821	Other Identifier	Children's Oncology Group
ADVL0821	Other Identifier	Children's Oncology Group
ADVL0821	Other Identifier	CTEP
U10CA098543	U.S. NIH Grant/Contract		View source

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 - Recurrent or Refractory Hepatoblastoma	Experimental	Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.	Biological: cixutumumab Other: laboratory biomarker analysis
Group 2 - Recurrent or Refractory Synovial Sarcoma	Experimental	Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.	Biological: cixutumumab Other: laboratory biomarker analysis
Group 3 - Recurrent or Refractory Rhabdomyosarcoma	Experimental	Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.	Biological: cixutumumab Other: laboratory biomarker analysis
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma	Experimental	Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cixutumumab	Biological	Given IV: Week 1 day 1, 9 mg/kg/dose over 1 hour. Week 2 Day 8, 9 mg/kg/dose over 1 hour. Week 3 Day 15, 9 mg/kg/dose over 1 hour. Week 4 Day 22, 9 mg/kg/dose over 1 hour.

Measure	Description	Time Frame
Disease Response	Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).	First six treatment cycles - 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed malignant solid tumor, including the following:
- Osteosarcoma
- Ewing sarcoma/peripheral primitive neuroectodermal tumor
- Rhabdomyosarcoma
- Neuroblastoma
- Wilms tumor
- Synovial sarcoma
- Hepatoblastoma
- Adrenocortical carcinoma
- Retinoblastoma
No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan
- The following are not considered measurable disease:
  - Ascites, pleural effusions, or other malignant fluid collections
  - Bone marrow infiltration by tumor
  - Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)
  - Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy
No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months
Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2
Absolute neutrophil count (ANC) ≥ 1,000/mm³ (> 250/mm³ for patients with neuroblastoma)
Platelet count ≥ 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma) (transfusion independent)
Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows:
- ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
- ≤ 0.5 mg/dL (for patients 6 to 11 months of age)
- ≤ 0.6 mg/dL (for patients 1 year of age)
- ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
- ≤ 1 mg/dL (for patients 6 to 9 years of age)
- ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
- ≤ 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- ≤ 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
Total bilirubin ≤ 1.5 times upper limit of normal for age
Alanine transaminase (ALT) ≤ 110 U/L
Serum albumin ≥ 2 g/dL
Blood glucose normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to comply with safety monitoring requirements of study
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
No uncontrolled infection
No known type I or II diabetes mellitus
Recovered from prior chemotherapy, immunotherapy, or radiotherapy
More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)
At least 6 weeks since prior monoclonal antibody therapy
At least 7 days since other prior antineoplastic biologic agents
No prior monoclonal antibody targeting the IGF-IR
No prior small molecule kinase inhibitors of IGF-IR
At least 2 weeks since prior local palliative (small port) radiotherapy
At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
At least 6 weeks since other prior substantial bone marrow radiotherapy
At least 2 months since prior stem cell transplantation
- No evidence of graft-versus-host disease
Concurrent corticosteroids allowed provided dose is stable or decreasing over the past 7 days
- Intermittent use of corticosteroids to manage infusional reactions allowed
No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
No other concurrent investigational agents
No concurrent insulin or growth hormone therapy

Name	Affiliation	Role
Brenda Weigel, MD	Children's Oncology Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
University of Arkansas for Medical Sciences

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1 - Recurrent or Refractory Hepatoblastoma	Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Group 1 - Recurrent or Refractory Hepatoblastoma	Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG001	Group 2 - Recurrent or Refractory Synovial Sarcoma	Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG002	Group 3 - Recurrent or Refractory Rhabdomyosarcoma	Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG003	Grp 4-Recurrent or Refractory Adrenocortical Carcinoma	Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG004	Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor	Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG005	Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease	Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG006	Grp 7-Neuroblastoma With Measurable Disease	Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG007	Group 8 - Recurrent Osteosarcoma	Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG008	Group 9 - Recurrent or Refractory Wilms Tumor	Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG009	Group 10 - Recurrent or Refractory Retinoblastoma	Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
BG010	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

Disease Response

Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).

Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).

Posted

Number

patient

First six treatment cycles - 24 weeks

ID	Title	Description
OG000	Group 1 - Recurrent or Refractory Hepatoblastoma	Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG001	Group 2 - Recurrent or Refractory Synovial Sarcoma	Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG002	Group 3 - Recurrent or Refractory Rhabdomyosarcoma	Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG003	Grp 4-Recurrent or Refractory Adrenocortical Carcinoma	Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG004	Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor	Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG005	Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease	Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG006	Grp 7-Neuroblastoma With Measurable Disease	Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG007	Group 8 - Recurrent Osteosarcoma	Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG008	Group 9 - Recurrent or Refractory Wilms Tumor	Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
OG009	Group 10 - Recurrent or Refractory Retinoblastoma	Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies

Units	Counts
Participants	OG00010 OG00110 OG00220 OG003

Title

Denominators

Categories

Non-Responder

Title	Measurements
	OG00010 OG00110 OG00219 OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1 - Recurrent or Refractory Hepatoblastoma	Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	7	10	5	10
EG001	Group 2 - Recurrent or Refractory Synovial Sarcoma	Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	3	10	7	10
EG002	Group 3 - Recurrent or Refractory Rhabdomyosarcoma	Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4	20	14	20
EG003	Grp 4-Recurrent or Refractory Adrenocortical Carcinoma	Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5	10	5	10
EG004	Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor	Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5	13	8	13
EG005	Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease	Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5	20	9	20
EG006	Grp 7-Neuroblastoma With Measurable Disease	Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4	10	9	10
EG007	Group 8 - Recurrent Osteosarcoma	Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4	9	5	9
EG008	Group 9 - Recurrent or Refractory Wilms Tumor	Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5	9	9	9
EG009	Group 10 - Recurrent or Refractory Retinoblastoma	Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	0	0	0	0

Serious Adverse Events

Term	Organ System	Statistical Information
Abdominal pain	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG0030 affected10 at risk EG0040 affected13 at risk EG0052 affected20 at risk EG0060 affected10 at risk EG0070 affected9 at risk EG0080 affected9 at risk EG0090 affected0 at risk
Acidosis	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	EG0002 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Anaphylaxis	Immune system disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Anemia	Blood and lymphatic system disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Anorexia	Metabolism and nutrition disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Appendicitis	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Asystole	Cardiac disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bladder infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Chest wall pain	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Confusion	Psychiatric disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Creatinine increased	Investigations	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cystitis noninfective	Renal and urinary disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Death NOS	General disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	EG0003 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Device related infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Diarrhea	Gastrointestinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dry mouth	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Fatigue	General disorders	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
GGT increased	Investigations	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Headache	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypermagnesemia	Metabolism and nutrition disorders	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypertension	Vascular disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypotension	Vascular disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypothyroidism	Endocrine disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Infections and infestations - Other	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
INR increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Intra-abdominal hemorrhage	Gastrointestinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Investigations - Other	Investigations	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lymphocyte count decreased	Investigations	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Neutrophil count decreased	Investigations	EG0002 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Non-cardiac chest pain	General disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pain	General disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pelvic pain	Reproductive system and breast disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Platelet count decreased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Postoperative hemorrhage	Injury, poisoning and procedural complications	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Proteinuria	Renal and urinary disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Renal and urinary disorders - Other	Renal and urinary disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Syncope	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Upper respiratory infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Urinary tract infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	EG0002 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
White blood cell decreased	Investigations	EG0002 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal pain	Gastrointestinal disorders	EG0001 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG0031 affected10 at risk EG0040 affected13 at risk EG0051 affected20 at risk EG0061 affected10 at risk EG0070 affected9 at risk EG0081 affected9 at risk EG0090 affected0 at risk
Agitation	Psychiatric disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Alkaline phosphatase increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Allergic reaction	Immune system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Anemia	Blood and lymphatic system disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0024 affected20 at risk EG003
Anorexia	Metabolism and nutrition disorders	EG0001 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Anxiety	Psychiatric disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Bladder infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Bladder spasm	Renal and urinary disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Blood bilirubin increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Bruising	Injury, poisoning and procedural complications	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Burn	Injury, poisoning and procedural complications	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cognitive disturbance	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Creatinine increased	Investigations	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cushingoid	Endocrine disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cytokine release syndrome	Immune system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Depression	Psychiatric disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Diarrhea	Gastrointestinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dizziness	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Endocrine disorders - Other	Endocrine disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Extrapyramidal disorder	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Eye infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fatigue	General disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Fever	General disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fibrinogen decreased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fracture	Injury, poisoning and procedural complications	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Gait disturbance	General disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
GGT increased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Headache	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypertension	Vascular disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypertriglyceridemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	EG0001 affected10 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	EG0001 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	EG0000 affected10 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lung infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lymphocyte count decreased	Investigations	EG0001 affected10 at risk EG0012 affected10 at risk EG0023 affected20 at risk EG003
Memory impairment	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mucositis oral	Gastrointestinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Neutrophil count decreased	Investigations	EG0000 affected10 at risk EG0011 affected10 at risk EG0025 affected20 at risk EG003
Non-cardiac chest pain	General disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Otitis externa	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Otitis media	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pain	General disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0001 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Pelvic pain	Reproductive system and breast disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Platelet count decreased	Investigations	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Proteinuria	Renal and urinary disorders	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Psychosis	Psychiatric disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinus tachycardia	Cardiac disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinusitis	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Skin infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Toothache	Gastrointestinal disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tracheitis	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Upper respiratory infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Urinary tract infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Urinary tract pain	Renal and urinary disorders	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	EG0001 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Weight loss	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
White blood cell decreased	Investigations	EG0000 affected10 at risk EG0010 affected10 at risk EG0024 affected20 at risk EG003
Wound infection	Infections and infestations	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003

Ancestor Terms

ID	Term
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009372	Neoplasms, Connective Tissue
D018193	Neoplasms, Complex and Mixed
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D000306	Adrenal Cortex Neoplasms
D000310	Adrenal Gland Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D000303	Adrenal Cortex Diseases
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D018213	Neoplasms, Bone Tissue
D009373	Neoplasms, Germ Cell and Embryonal
D009380	Neoplasms, Nerve Tissue
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D019572	Retinal Neoplasms
D005134	Eye Neoplasms
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D012164	Retinal Diseases
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009386	Neoplastic Syndromes, Hereditary
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D012208	Rhabdomyosarcoma
D013584	Sarcoma, Synovial
D018197	Hepatoblastoma
D018268	Adrenocortical Carcinoma
D012509	Sarcoma
D012512	Sarcoma, Ewing
D017599	Neuroectodermal Tumors
D009447	Neuroblastoma
D012516	Osteosarcoma
D012175	Retinoblastoma
D009396	Wilms Tumor