Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002249-39 | EudraCT Number |
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab 3 mg/kg | Experimental | Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
|
| Ipilimumab 10 mg/kg | Experimental | Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate at 1 Year | Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment. | 1 year following start of treatment (Assessed up to June 2016, approximately 38 months) |
| Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs) | The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment. | From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s). |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children'S Hospital | Phoenix | Arizona | 85016 | United States | ||
| Childrens Hospital Of La |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29100190 | Derived | Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
14 participants were enrolled in the study. 12 participants received study treatment. 2 participants were enrolled and not treated because they no longer met study criteria.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab 3mg/kg | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
| FG001 | Ipilimumab 10mg/kg | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) |
| Progression Free Survival | Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment. | From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months) |
| Best Overall Response Rate (BORR) | Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s). | From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) |
| Overall Survival Time | Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date). | From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months) |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children'S Hospital Of Orange County | Orange | California | 92868 | United States |
| Children'S Hospital Colorado | Aurora | Colorado | 80045 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| James Whitcomb Riley Hospital For Children | Indianapolis | Indiana | 46202 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University Of Pittsburgh Medical Center Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| St. Jude Children'S Research Hospital | Memphis | Tennessee | 38105 | United States |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Primary Children'S Medical Center | Salt Lake City | Utah | 84113 | United States |
| University Of Utah | Salt Lake City | Utah | 84113 | United States |
| Local Institution | Ghent | 9000 | Belgium |
| Local Institution | Copenhagen | 2100 | Denmark |
| Local Institution | Lyon | 69008 | France |
| Local Institution | Marseille | 13385 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Dortmund | 44137 | Germany |
| Local Institution | Erlangen | 91054 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | M?nster | 48149 | Germany |
| Local Institution | Münster | 48149 | Germany |
| Local Institution | México | D.F | 02990 | Mexico |
| Local Institution | Leon, Guanajato | Guanajuato | 37000 | Mexico |
| Local Institution | Df | Mexico City | 06720 | Mexico |
| Local Institution | Esplugues de Llobregat- Barcelona | 08950 | Spain |
| Local Institution | Bristol | Avon | BS2 8BJ | United Kingdom |
| Local Institution | Newcastle | Northumberland | NE1 4LP | United Kingdom |
| Local Institution | Sutton | Surrey | SM2 5PT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab 3mg/kg | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
| BG001 | Ipilimumab 10mg/kg | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Overall Survival (OS) Rate at 1 Year | Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment. | All treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year following start of treatment (Assessed up to June 2016, approximately 38 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs) | The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment. | All treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s). | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment. | All treated participants | Posted | Median | 95% Confidence Interval | months | From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response Rate (BORR) | Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s). | All treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Time | Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date). | All treated participants | Posted | Median | 95% Confidence Interval | months | From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months) |
|
|
From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
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 | IPILIMUMAB 3 MG/KG | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. | 1 | 4 | 4 | 4 | ||
| EG001 | IPILIMUMAB 10 MG/KG | Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. | 6 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Coagulation factor increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | clinical.trials@bms.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|