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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-JE-JVCL | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab | Experimental | Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks) | The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first. | Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 464-8681 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29508095 | Derived | Yamaguchi K, Fujitani K, Nagashima F, Omuro Y, Machida N, Nishina T, Koue T, Tsujimoto M, Maeda K, Satoh T. Ramucirumab for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum- or fluoropyrimidine-containing combination therapy in Japanese patients: a phase 2, open-label study. Gastric Cancer. 2018 Nov;21(6):1041-1049. doi: 10.1007/s10120-018-0811-4. Epub 2018 Mar 5. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participant study completion was defined as participant assessment at the 12-week visit or withdrawal from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab 8 mg/kg | Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab 8 mg/kg | Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks) | The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate. | Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug. 8 participants were censored. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 12 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramucirumab 8 mg/kg | Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100. | Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks) |
| Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)] | Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100. | Baseline to Measured PD or Death from Any Cause (Up to 12 Months) |
| Overall Survival (OS) | The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive. | Baseline to Death from Any Cause (Up to 13 Months) |
| Number of Participants With Anti-Ramucirumab Antibodies | A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive. | Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab | Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose |
| PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab | Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 260-8717 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ehime | 791-0280 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | 060-8648 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 650-0047 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 224-8503 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 558-8558 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 569-8686 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | 362-0806 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shizuoka | 411-8777 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 181-8611 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Eastern Cooperative Oncology Group performance status (ECOG PS) 0 vs. 1 | 0 = Fully active, able to carry on all pre-disease performance without restriction, 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work | Number | Participants |
|
| Basis for Pathological Diagnosis | Number | Participants |
|
| Pathological Diagnosis | Number | Participants |
|
| Initial Tumor Location | Number | Participants |
|
| Human Epidermal Growth Factor Receptor 2 (HER2) Status | Number | Participants |
|
| Grade | Number | Participants |
|
| Histology | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Progression-Free Survival (PFS) | The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first. | FAS: all enrolled participants who received at least one dose of the study drug. 8 participants were censored. | Posted | Median | 90% Confidence Interval | Weeks | Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks) |
|
|
|
| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100. | FAS: all enrolled participants who received at least one dose of the study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks) |
|
|
|
| Secondary | Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)] | Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100. | FAS: all enrolled participants who received at least one dose of the study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline to Measured PD or Death from Any Cause (Up to 12 Months) |
|
|
|
| Secondary | Overall Survival (OS) | The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive. | FAS: all enrolled participants who received at least one dose of the study drug. 18 participants were censored. | Posted | Median | 90% Confidence Interval | Months | Baseline to Death from Any Cause (Up to 13 Months) |
|
|
|
| Secondary | Number of Participants With Anti-Ramucirumab Antibodies | A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive. | All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data. | Posted | Number | participants | Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab | PK population: enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (μg/mL) | Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose |
|
|
|
| Secondary | PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab | PK population: Enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours x micrograms/milliliters (h*μg/mL) | Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose |
|
|
|
| 7 |
| 36 |
| 35 |
| 36 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |