Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA076292 | U.S. NIH Grant/Contract | View source | |
| P30CA014089 | U.S. NIH Grant/Contract | View source | |
| MCC-15241 | Other Identifier | Moffitt Cancer Center | |
| MDX010-16 | Other Identifier | Medarex | |
| NCI-6446 | Other Identifier | National Cancer Institute | |
| CA184-016 | Other Identifier | BMS |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma.
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipilimumab | Biological | IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Immune-related Adverse Events (irAEs) | Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events < or = Grade 3 (potentially reversible inflammation < Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
| Time to Disease Relapse | To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-related irAEs of Any Grade | The number of participants who experienced a drug-related irAE of any grade over the course of the study. Note: The confidence interval was calculated using the Clopper Pearson method | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Completely resected within the past 6 months
Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
Positive staining of tumor tissue for at least one of the following:
HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No history of any of the following:
No systemic hypersensitivity to Montanide ISA-51 or any vaccine component
No active infection requiring therapy
HIV negative
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32161584 | Derived | Garg SK, Ott MJ, Mostofa AGM, Chen Z, Chen YA, Kroeger J, Cao B, Mailloux AW, Agrawal A, Schaible BJ, Sarnaik A, Weber JS, Berglund AE, Mule JJ, Markowitz J. Multi-Dimensional Flow Cytometry Analyses Reveal a Dichotomous Role for Nitric Oxide in Melanoma Patients Receiving Immunotherapy. Front Immunol. 2020 Feb 25;11:164. doi: 10.3389/fimmu.2020.00164. eCollection 2020. | |
| 21106722 | Derived | Sarnaik AA, Yu B, Yu D, Morelli D, Hall M, Bogle D, Yan L, Targan S, Solomon J, Nichol G, Yellin M, Weber JS. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011 Feb 15;17(4):896-906. doi: 10.1158/1078-0432.CCR-10-2463. Epub 2010 Nov 24. |
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77 participants enrolled, 76 treated. 1 not treated due to protocol violation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3.0 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| FG001 | 10 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| FG002 | 10 MG/KG IPILIMUMAB | HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 3.0 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| BG001 |
| 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 With Immune-related Adverse Events (irAEs) | Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events < or = Grade 3 (potentially reversible inflammation < Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method | All treated participants | Posted | Number | 90% Confidence Interval | Percentage of participants | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
|
From first dose to 70 days post last dose (up to 3 years)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3.0 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D014442 | Monophenol Monooxygenase |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Tyrosinase/gp100/MART-1 Peptides | Biological | (All subjects in Part I and HLA-A*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.) |
|
| Immunologic Response to the Dose Regimen | The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative. Note: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive. A participant with all negative post-baseline results is counted as HAHA negative. | up to 3 years |
| Number of Participants Experiencing Hematology-related Lab Abnormalities | The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
| Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities | The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
| Time to Disease Relapse | To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method. | up to 3 years |
| Disease relapse |
|
| Disease progression |
|
| Lost to Follow-up |
|
| 10 MG/KG IPILIMUMAB + PEPTIDES |
HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| BG002 | 10 MG/KG IPILIMUMAB | HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
HLA-A*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
| OG001 | 10 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. |
| OG002 | 10 MG/KG IPILIMUMAB | HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. |
|
|
| Primary | Time to Disease Relapse | To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method. | All treated participants for the 10 mg/kg ipilimumab arms of the study only | Posted | Median | 95% Confidence Interval | Months | up to 3 years |
|
|
|
| Secondary | Number of Participants With Drug-related irAEs of Any Grade | The number of participants who experienced a drug-related irAE of any grade over the course of the study. Note: The confidence interval was calculated using the Clopper Pearson method | All treated participants | Posted | Count of Participants | Participants | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
|
|
|
| Secondary | Immunologic Response to the Dose Regimen | The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative. Note: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive. A participant with all negative post-baseline results is counted as HAHA negative. | All Treated Subjects with Baseline and at Least one Post-Baseline HAHA Assessment | Posted | Number | Number of participants | up to 3 years |
|
|
|
| Secondary | Number of Participants Experiencing Hematology-related Lab Abnormalities | The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. | All treated participants | Posted | Number | Number of participants | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
|
|
|
| Secondary | Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities | The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. | All treated participants | Posted | Number | Number of participants | Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) |
|
|
|
| Secondary | Time to Disease Relapse | To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method. | All treated participants for the 3 mg/kg ipilimumab arm of the study only | Posted | Median | 95% Confidence Interval | Months | up to 3 years |
|
|
|
| 0 |
| 25 |
| 5 |
| 25 |
| 25 |
| 25 |
| EG001 | 10 MG/KG IPILIMUMAB + PEPTIDES | HLA-A*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. | 0 | 25 | 7 | 25 | 25 | 25 |
| EG002 | 10 MG/KG IPILIMUMAB | HLA-A*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. | 0 | 26 | 10 | 26 | 25 | 26 |
| Hypophysitis | Endocrine disorders | 13.0 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | 13.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Megacolon | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | 13.0 | Systematic Assessment |
|
| Hernia obstructive | General disorders | 13.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 13.0 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | 13.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | 13.0 | Systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | 13.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | 13.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | 13.0 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | 13.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 13.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | 13.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | 13.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | 13.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | 13.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | 13.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 13.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 13.0 | Systematic Assessment |
|
| Chills | General disorders | 13.0 | Systematic Assessment |
|
| Face oedema | General disorders | 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | 13.0 | Systematic Assessment |
|
| Granuloma | General disorders | 13.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | 13.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | 13.0 | Systematic Assessment |
|
| Injection site nodule | General disorders | 13.0 | Systematic Assessment |
|
| Injection site pain | General disorders | 13.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | 13.0 | Systematic Assessment |
|
| Injection site rash | General disorders | 13.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | 13.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | 13.0 | Systematic Assessment |
|
| Injection site vesicles | General disorders | 13.0 | Systematic Assessment |
|
| Irritability | General disorders | 13.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | 13.0 | Systematic Assessment |
|
| Oedema | General disorders | 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 13.0 | Systematic Assessment |
|
| Pain | General disorders | 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 13.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 13.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 13.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 13.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 13.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 13.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 13.0 | Systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | 13.0 | Systematic Assessment |
|
| Blood testosterone decreased | Investigations | 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | 13.0 | Systematic Assessment |
|
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 13.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 13.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | 13.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 13.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | 13.0 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004156 | Catechol Oxidase |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| Title | Measurements |
|---|---|
|
| HAHA negative |
|
|
| Absolute Neutrophil Count, grade 1-4 |
|
| Absolute Neutrophil Count, grade 3-4 |
|
| Platelet Count, grade 1-4 |
|
| Platelet Count, grade 3-4 |
|
| Hemoglobin, grade 1-4 |
|
| Hemoglobin, grade 3-4 |
|
| Lymphocytes, grade 1-4 |
|
| Lymphocytes, grade 3-4 |
|
| alanine aminotransferase (ALT), grade 3-4 |
|
|
| aspartate aminotransferase (AST), grade 1-4 |
|
|
| aspartate aminotransferase (AST), grade 3-4 |
|
|
| Total Bilirubin, grade 1-4 |
|
|
| Total Bilirubin, grade 3-4 |
|
|
| Alkaline Phosphatase, grade 1-4 |
|
|
| Alkaline Phosphatase, grade 3-4 |
|
|
| Amylase, grade 1-4 |
|
|
| Amylase, grade 3-4 |
|
|
| Lipase, grade 1-4 |
|
|
| Lipase, grade 3-4 |
|
|
| Creatinine, grade 1-4 |
|
|
| Creatinine, grade 3-4 |
|
|