S1201: Combination Chemo for Patients W/Advanced or Metas... | NCT01498289

NCT01498289

ID	Type	Description	Link
S1201	Other Identifier	SWOG
U10CA032102	U.S. NIH Grant/Contract		View source
NCI-2012-00096	Other Identifier	CTRP

Status Module

Sponsor/Collaborators Module

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Description Module

Detailed Description

OBJECTIVES:

To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus docetaxel.
To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated with irinotecan hydrochloride plus docetaxel.
To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1 patients treated with FOLFOX.
To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.
To assess the response probability (confirmed and unconfirmed, complete and partial responses) in the subset of patients with measurable disease in each of the two treatment arms.
To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)
To bank tissue and blood for future translational medicine studies; a) To explore the relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with clinical outcome in these patients; and b) To explore the association between germline variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.

Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm I	Experimental	FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.	Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin
Arm II	Experimental	Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: docetaxel Drug: irinotecan hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
FOLFOX regimen	Drug	Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.	Arm I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) in High-ERCC1 Patients	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.	Up to 3 years after registration
PFS in Low-ERCC1 Participants	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.	Up to 3 years after registration
Overall Survival (OS)	OS is the length of time between protocol registration and patient death	Up to 3 years after registration

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
- Patients must not have received treatment for metastatic or unresectable disease
- Patients must not have brain metastases
Patients must have measurable and/or non-measurable disease
Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration

PATIENT CHARACTERISTICS:

Zubrod performance status of 0-1
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min
Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
All palliative radiation therapy alone must be completed at least 14 days prior to registration
Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment

Contacts/Locations Module

Name	Affiliation	Role
Syma Iqbal, MD	University of Southern California	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Mitchell Cancer Institute		Mobile	Alabama	36688	United States
University of Arkansas for Medical Sciences

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm I	FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Apr 28, 2014

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.

Arm/Group Information

ID	Title	Description
BG000	Arm I	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
BG001	Arm II	Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00062.5(21.5 to 85.6) BG00162.4(33.7 to 84.8) BG00262.5(21.5 to 85.8)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG00121 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00119 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

ERCC1

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
High (>=1.7)	BG00013 BG00115 BG002

Site of Disease

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Esophageal	BG00033 BG00136 BG002

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

Progression-free Survival (PFS) in High-ERCC1 Patients

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Eligible and analyzable participants with ERCC1 level >= 1.7

Posted

Median

95% Confidence Interval

months

Up to 3 years after registration

ID	Title	Description
OG000	Arm I FOLFOX	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
OG001	Arm II IT	IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Units	Counts
Participants	OG00013 OG00115

Title

Denominators

Categories

Title	Measurements
	OG0004.7(2.1 to 8.7) OG0015.3(0.9 to 11.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.83		Cox Proportional Hazard	0.91			2-Sided	95	0.41	2.05					Superiority

Primary

PFS in Low-ERCC1 Participants

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Eligible and analyzable participants with ERCC1 level < 1.7

Posted

Median

95% Confidence Interval

months

Up to 3 years after registration

ID	Title	Description
OG000	Arm I	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
OG001	Arm II	IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Primary

Overall Survival (OS)

OS is the length of time between protocol registration and patient death

Eligible and analyzable participants

Posted

Median

95% Confidence Interval

months

Up to 3 years after registration

ID	Title	Description
OG000	Arm I	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
OG001	Arm II	IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Secondary

Overall Response Rate (ORR)

ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

Participants with measurable disease

Posted

Number

95% Confidence Interval

percentage of evaluable participants

Up to 3 years after registration

ID	Title	Description
OG000	Arm I	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
OG001	Arm II	IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Secondary

PFS Variation by ERCC1

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.

Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.

Posted

Median

95% Confidence Interval

months

up to 3 years after registration

ID	Title	Description
OG000	Arm I	FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
OG001	Arm II	IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Secondary

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment

Posted

Number

Participants

Duration of treatment and follow up until death or 3 years post registration

ID	Title	Description
OG000	Arm I FOLFOX	FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.
OG001	Arm II IT	IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

Units	Counts

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	Arm I FOLFOX	FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.	89	98	7	91	88	91
EG001	Arm II IT	IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.	94	104	17	98	95	98

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Mucositis oral	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Death NOS	General disorders	Systematic Assessment	EG0002 affected91 at risk EG0014 affected98 at risk
Multi-organ failure	General disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Sudden death NOS	General disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Lung infection	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0016 affected98 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Neoplasms benign, malignant and unspecified - Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected91 at risk EG0015 affected98 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00065 affected91 at risk EG00170 affected98 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected91 at risk EG0016 affected98 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Lymph node pain	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Cardiac disorders-Other	Cardiac disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0002 affected91 at risk EG0019 affected98 at risk
Hearing impaired	Ear and labyrinth disorders	Systematic Assessment	EG0002 affected91 at risk EG0011 affected98 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Endocrine disorders-Other	Endocrine disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Blurred vision	Eye disorders	Systematic Assessment	EG0006 affected91 at risk EG0014 affected98 at risk
Conjunctivitis	Eye disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Dry eye	Eye disorders	Systematic Assessment	EG0002 affected91 at risk EG0013 affected98 at risk
Eye disorders-Other	Eye disorders	Systematic Assessment	EG0000 affected91 at risk EG0013 affected98 at risk
Eye pain	Eye disorders	Systematic Assessment	EG0002 affected91 at risk EG0010 affected98 at risk
Vitreous hemorrhage	Eye disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Watering eyes	Eye disorders	Systematic Assessment	EG0002 affected91 at risk EG0015 affected98 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0003 affected91 at risk EG0013 affected98 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG00032 affected91 at risk EG00140 affected98 at risk
Anal fistula	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Anal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0005 affected91 at risk EG0014 affected98 at risk
Bloating	Gastrointestinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0015 affected98 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00043 affected91 at risk EG00133 affected98 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00033 affected91 at risk EG00168 affected98 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0006 affected91 at risk EG0013 affected98 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0006 affected91 at risk EG0017 affected98 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG00025 affected91 at risk EG00123 affected98 at risk
Esophageal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Esophageal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Esophageal pain	Gastrointestinal disorders	Systematic Assessment	EG0003 affected91 at risk EG0014 affected98 at risk
Esophageal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Esophagitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0016 affected98 at risk
Fecal incontinence	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0007 affected91 at risk EG0018 affected98 at risk
Gastric fistula	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Gastric hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0008 affected91 at risk EG0014 affected98 at risk
Gastrointestinal disorders-Other	Gastrointestinal disorders	Systematic Assessment	EG0003 affected91 at risk EG0013 affected98 at risk
Gastrointestinal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0012 affected98 at risk
Gastroparesis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0004 affected91 at risk EG0011 affected98 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Jejunal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Lip pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Malabsorption	Gastrointestinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Mucositis oral	Gastrointestinal disorders	Systematic Assessment	EG00030 affected91 at risk EG0019 affected98 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00060 affected91 at risk EG00162 affected98 at risk
Obstruction gastric	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Oral hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Oral pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Rectal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0010 affected98 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0014 affected98 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00038 affected91 at risk EG00144 affected98 at risk
Chills	General disorders	Systematic Assessment	EG0009 affected91 at risk EG0015 affected98 at risk
Edema face	General disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Edema limbs	General disorders	Systematic Assessment	EG00020 affected91 at risk EG00125 affected98 at risk
Edema trunk	General disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Facial pain	General disorders	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Fatigue	General disorders	Systematic Assessment	EG00074 affected91 at risk EG00171 affected98 at risk
Fever	General disorders	Systematic Assessment	EG0006 affected91 at risk EG00112 affected98 at risk
Flu like symptoms	General disorders	Systematic Assessment	EG0002 affected91 at risk EG0010 affected98 at risk
Gait disturbance	General disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
General disorders and admin site conditions - Other	General disorders	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Infusion related reaction	General disorders	Systematic Assessment	EG0002 affected91 at risk EG0012 affected98 at risk
Injection site reaction	General disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Irritability	General disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Localized edema	General disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Malaise	General disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0005 affected91 at risk EG0016 affected98 at risk
Pain	General disorders	Systematic Assessment	EG0008 affected91 at risk EG0016 affected98 at risk
Gallbladder pain	Hepatobiliary disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Portal vein thrombosis	Hepatobiliary disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Allergic reaction	Immune system disorders	Systematic Assessment	EG0006 affected91 at risk EG0013 affected98 at risk
Bladder infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Bronchial infection	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Enterocolitis infectious	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Eye infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Infections and infestations-Other	Infections and infestations	Systematic Assessment	EG0002 affected91 at risk EG0014 affected98 at risk
Lip infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Lung infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Lymph gland infection	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Mucosal infection	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Otitis media	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Peritoneal infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Rhinitis infective	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0003 affected91 at risk EG0014 affected98 at risk
Tooth infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0013 affected98 at risk
Tracheitis	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0005 affected91 at risk EG0015 affected98 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Vaginal infection	Infections and infestations	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Burn	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected91 at risk EG0013 affected98 at risk
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Injury, poison and procedural complications - Other	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Vascular access complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Activated partial thromboplastin time prolonged	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00019 affected91 at risk EG00120 affected98 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG00039 affected91 at risk EG00131 affected98 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00026 affected91 at risk EG00128 affected98 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG00013 affected91 at risk EG00110 affected98 at risk
CD4 lymphocytes decreased	Investigations	Systematic Assessment	EG0004 affected91 at risk EG0017 affected98 at risk
Cholesterol high	Investigations	Systematic Assessment	EG0002 affected91 at risk EG0012 affected98 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0002 affected91 at risk EG00113 affected98 at risk
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
INR increased	Investigations	Systematic Assessment	EG0001 affected91 at risk EG0013 affected98 at risk
Investigations-Other	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Lipase increased	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG00027 affected91 at risk EG00126 affected98 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG00047 affected91 at risk EG00130 affected98 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG00050 affected91 at risk EG00112 affected98 at risk
Serum amylase increased	Investigations	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Weight gain	Investigations	Systematic Assessment	EG0005 affected91 at risk EG0012 affected98 at risk
Weight loss	Investigations	Systematic Assessment	EG00037 affected91 at risk EG00132 affected98 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG00050 affected91 at risk EG00141 affected98 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG00040 affected91 at risk EG00146 affected98 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG00013 affected91 at risk EG00135 affected98 at risk
Glucose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected91 at risk EG0013 affected98 at risk
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00042 affected91 at risk EG00136 affected98 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected91 at risk EG0017 affected98 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Hypernatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected91 at risk EG0014 affected98 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Hyperuricemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG00044 affected91 at risk EG00151 affected98 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG00030 affected91 at risk EG00134 affected98 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0005 affected91 at risk EG0014 affected98 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00020 affected91 at risk EG00131 affected98 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected91 at risk EG0019 affected98 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG00021 affected91 at risk EG00135 affected98 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected91 at risk EG0014 affected98 at risk
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected91 at risk EG0013 affected98 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 affected91 at risk EG00112 affected98 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00013 affected91 at risk EG00112 affected98 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected91 at risk EG0013 affected98 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected91 at risk EG0011 affected98 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 affected91 at risk EG00117 affected98 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Musculoskeletal and connective tiss disorder - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected91 at risk EG0011 affected98 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 affected91 at risk EG0015 affected98 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 affected91 at risk EG0011 affected98 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 affected91 at risk EG0016 affected98 at risk
Neoplasms benign, malignant and unspecified - Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Ataxia	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Cognitive disturbance	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG00016 affected91 at risk EG00120 affected98 at risk
Dysesthesia	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG00019 affected91 at risk EG00119 affected98 at risk
Dysphasia	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Extrapyramidal disorder	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00011 affected91 at risk EG0019 affected98 at risk
Hypersomnia	Nervous system disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Ischemia cerebrovascular	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Memory impairment	Nervous system disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Nervous system disorders-Other	Nervous system disorders	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG00018 affected91 at risk EG0013 affected98 at risk
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0004 affected91 at risk EG0011 affected98 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00057 affected91 at risk EG00118 affected98 at risk
Sinus pain	Nervous system disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0004 affected91 at risk EG0014 affected98 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG00015 affected91 at risk EG00116 affected98 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0003 affected91 at risk EG0012 affected98 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG00015 affected91 at risk EG0019 affected98 at risk
Hallucinations	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00014 affected91 at risk EG00113 affected98 at risk
Libido decreased	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Personality change	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Psychiatric disorders-Other	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0002 affected91 at risk EG0013 affected98 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0002 affected91 at risk EG0013 affected98 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0002 affected91 at risk EG0010 affected98 at risk
Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Renal calculi	Renal and urinary disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Urinary frequency	Renal and urinary disorders	Systematic Assessment	EG0002 affected91 at risk EG0013 affected98 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0002 affected91 at risk EG0012 affected98 at risk
Irregular menstruation	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Nipple deformity	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Testicular pain	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected91 at risk EG0016 affected98 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0011 affected98 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00020 affected91 at risk EG00121 affected98 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00016 affected91 at risk EG00120 affected98 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00011 affected91 at risk EG0015 affected98 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected91 at risk EG0017 affected98 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0012 affected98 at risk
Laryngopharyngeal dysesthesia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected91 at risk EG0010 affected98 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected91 at risk EG0012 affected98 at risk
Pharyngeal mucositis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0016 affected98 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected91 at risk EG0011 affected98 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected91 at risk EG0014 affected98 at risk
Resp, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected91 at risk EG0011 affected98 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0010 affected98 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected91 at risk EG0013 affected98 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0013 affected98 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00010 affected91 at risk EG00130 affected98 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00011 affected91 at risk EG00110 affected98 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected91 at risk EG0015 affected98 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0014 affected98 at risk
Nail loss	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0012 affected98 at risk
Nail ridging	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0014 affected98 at risk
Pain of skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0008 affected91 at risk EG0012 affected98 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 affected91 at risk EG0016 affected98 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected91 at risk EG0015 affected98 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0007 affected91 at risk EG0017 affected98 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 affected91 at risk EG0010 affected98 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 affected91 at risk EG0010 affected98 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected91 at risk EG0011 affected98 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Flushing	Vascular disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Hematoma	Vascular disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk
Hot flashes	Vascular disorders	Systematic Assessment	EG0005 affected91 at risk EG0012 affected98 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00018 affected91 at risk EG00115 affected98 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0007 affected91 at risk EG00119 affected98 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG00010 affected91 at risk EG0017 affected98 at risk
Vascular disorders-Other	Vascular disorders	Systematic Assessment	EG0000 affected91 at risk EG0011 affected98 at risk

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms
C562730	Adenocarcinoma Of Esophagus

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
C410216	Folfox protocol
D000077143	Docetaxel
D005472	Fluorouracil
D000077146	Irinotecan
D002955	Leucovorin
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002166	Camptothecin
D000470	Alkaloids
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D056831	Coordination Complexes

Units	Counts
Participants	OG00085 OG00189