Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001429-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BMS-986004 | Experimental | BMS-986004 solution intravenously (IV) as specified |
|
| Arm B: BMS-986004 | Experimental | BMS-986004 solution intravenously as specified |
|
| Arm C: BMS-986004 | Experimental | BMS-986004 solution intravenously as specified |
|
| Arm D: BMS-986004 | Experimental | BMS-986004 solution intravenously as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986004 75 mg IV | Drug | BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term | The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
| Number of ECG Abnormalities | The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate) | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
| Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT) | D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml. | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) of BMS-986004: Short Term and Long Term | Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding. | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. Of Southern Calif. /Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
46 participants were enrolled in the study and 26 participants entered the treatment period. Of the 20 who did not enter the treatment period, 19 did not meet study criteria and 1 experienced an adverse event.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986004 75mg IV | BMS-986004 dose level 75 mg |
| FG001 | BMS-986004 225mg IV | BMS-986004 dose level 225 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Short Term Period |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2016 | Jan 17, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-986004 225 mg IV | Drug | BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes |
|
| BMS-986004 675 mg IV | Drug | BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes |
|
| BMS-986004 1500 mg IV | Drug | BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes |
|
| Maximum Observed Serum Concentration (Cmax) of BMS-986004 | Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| Trough Observed Serum Concentration (Ctrough) of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| Total Body Clearance (CLT) of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| AUC Accumulation Index (AI_AUC) of BMS-986004 | AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| Georgetown University Medical Center |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Rutgers- Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Local Institution | Randwick | New South Wales | 2031 | Australia |
| Local Institution | Brisbane | Queensland | 4102 | Australia |
| Hamilton Health Sciences/Mc Master Univ Med Ctre | Hamilton | Ontario | L8S 4K1 | Canada |
| Local Institution | Tbilisi | 0112 | Georgia |
| Local Institution | Chisinau | MD 2025 | Moldova |
| Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych | Chorzów | 41-500 | Poland |
| Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos | Lublin | 20-601 | Poland |
| Local Institution | Warsaw | 02-106 | Poland |
| Local Institution | Saint Petersburg | 194356 | Russia |
| Local Institution | Smolensk | Russia |
| Local Institution | London | Greater London | NW1 2PG | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M13 9WL | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | G4 OSF | United Kingdom |
| Local Institution | London | E1 1BB | United Kingdom |
| FG002 |
| BMS-986004 675 mg IV |
BMS-986004 dose level 675 mg |
| FG003 | BM-986004 1500 mg IV | BMS-986004 dose level 1500 mg |
| COMPLETED | Completed = Entering Long Term Extension |
|
| NOT COMPLETED |
|
|
| Long Term Extension |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BMS 75 mg | BMS-986004 dose level 75 mg |
| BG001 | BMS-986004 225mg IV | BMS-986004 dose level 225 mg |
| BG002 | BMS 675mg | BMS-986004 dose level 675 mg |
| BG003 | BMS 1500mg | BMS-986004 dose level 1500 mg |
| BG004 | 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 | All treated participants | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | All treated participants | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | All treated participants | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | All treated participants | 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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term | The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods | All participants who had received at least 1 dose of study treatment | Posted | Count of Participants | Participants | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of ECG Abnormalities | The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate) | All participants who had received at least 1 dose of study treatment | Posted | Number | Events | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT) | D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml. | All participants who had received at least 1 dose of study treatment | Posted | Number | Events | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate (RR) of BMS-986004: Short Term and Long Term | Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding. | All participants who had received at least 1 dose of study treatment | Posted | Number | Proportion of participants | Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) of BMS-986004 | Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Evaluable PK population defined as participants with adequate PK profiles. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Trough Observed Serum Concentration (Ctrough) of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Total Body Clearance (CLT) of BMS-986004 | Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study. | Posted | Mean | Standard Deviation | L/H | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | AUC Accumulation Index (AI_AUC) of BMS-986004 | AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group. | Evaluable PK Population. Only participants with adequate PK profiles were included in the summary statistics; "0" participants analyzed indicates "no data were available for that cohort for this Summary Statistic" | Posted | Mean | Standard Deviation | Ratio | Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h) |
|
All SAEs were collected that occurred during 21 day screening period, a 12 week treatment period (6 weeks of response Phase and 6 weeks of remission phase) and a 1 month follow up period. The collection of nonserious AE information began at initiation of study drug and up to follow up.
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 | BMS-986004 75mg IV | BMS-986004 dose level 75 mg | 0 | 5 | 0 | 5 | 1 | 5 |
| EG001 | BMS-986004 225mg IV | BMS-986004 dose level 225 mg | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | BMS 675mg | BMS-986004 dose level 675 mg | 0 | 5 | 2 | 5 | 5 | 5 |
| EG003 | BMS 1500mg | BMS-986004 dose level 1500 mg | 1 | 10 | 1 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Heart sounds abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neurosis | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Exercise lack of | Social circumstances | MedDRA 21.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 21.1 | 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 | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2015 | Jan 17, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Number of participants with SAEs |
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
BMS-986004 dose level 1500 mg |
|
|
| BMS 1500mg |
BMS-986004 dose level 1500 mg |
|
|
BMS-986004 dose level 1500 mg |
|
|
BMS-986004 dose level 1500 mg
|
|
BMS-986004 dose level 1500 mg
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
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