Trial Outcomes & Findings for Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923) (NCT NCT01357655)
NCT ID: NCT01357655
Last Updated: 2017-03-14
Results Overview
Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline up to 12 months
Results posted on
2017-03-14
Participant Flow
70 participants were enrolled, 66 were treated. Reasons for non-treatment include 1 adverse event and 3 no longer met study criteria. Participants enrolled were only treated with Dasatinib. The Dasatinib + SMO antagonist (BMS-833923) arm did not have participants because the recommended phase 2 dose of the SMO antagonist had not been determined.
Participant milestones
| Measure |
Dasatinib
Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
|
Dasatinib + SMO Antagonist (BMS-833923)
No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
0
|
Reasons for withdrawal
| Measure |
Dasatinib
Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
|
Dasatinib + SMO Antagonist (BMS-833923)
No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
|
|---|---|---|
|
Overall Study
Administrative Reason by Sponsor
|
45
|
0
|
|
Overall Study
Adverse Event Unrelated to Study Drug
|
3
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Maximum Clinical Benefit
|
2
|
0
|
|
Overall Study
Reason Unspecified
|
1
|
0
|
|
Overall Study
Study Drug Toxicity
|
11
|
0
|
|
Overall Study
Subject Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
Baseline characteristics by cohort
| Measure |
Dasatinib + SMO Antagonist (BMS-833923)
No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
|
Total
n=66 Participants
Total of all reporting groups
|
Dasatinib
n=66 Participants
Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=93 Participants
|
|
Age, Customized
Between 18 and 64 years
|
0 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
54 Participants
n=93 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
39 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Efficacy Sample: all treated participants with at least one assessment on treatment. Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.
Outcome measures
| Measure |
Dasatinib
n=64 Participants
Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
|
Dasatinib + SMO Antagonist (BMS-833923)
No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
|
|---|---|---|
|
Number of Participants With Major Molecular Response
Baseline
|
1 Participants
|
0 Participants
|
|
Number of Participants With Major Molecular Response
3 Months
|
9 Participants
|
0 Participants
|
|
Number of Participants With Major Molecular Response
6 Months
|
30 Participants
|
0 Participants
|
|
Number of Participants With Major Molecular Response
12 Months
|
34 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of study (approximately 48 months)Population: The study was terminated prior to data collection for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to End of study (approximately 48 months)Population: The study was terminated prior to data collection for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to End of study (approximately 48 months)Population: The study was terminated prior to data collection for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to End of study (approximately 48 months)Population: The study was terminated prior to data collection for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)Population: All Treated Participants; Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.
Outcome measures
| Measure |
Dasatinib
n=66 Participants
Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
|
Dasatinib + SMO Antagonist (BMS-833923)
No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
|
|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
SAE
|
18 participants
|
—
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
Drug-Related AE
|
56 participants
|
—
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
Death
|
2 participants
|
—
|
|
Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
AE Leading to Discontinuation
|
14 participants
|
—
|
Adverse Events
Dasatinib
Serious events: 18 serious events
Other events: 60 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dasatinib
n=66 participants at risk
Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
|
|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Vaginal abscess
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Colitis
|
3.0%
2/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.6%
5/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
2/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Hepatobiliary disorders
Cholecystitis acute
|
3.0%
2/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Cardiac disorders
Myocardial ischaemia
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Pneumonia
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Urosepsis
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Liver abscess
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Volvulus
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Eye disorders
Amaurosis fugax
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Apical granuloma
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Cardiac disorders
Cardiac tamponade
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
General disorders
Death
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
Other adverse events
| Measure |
Dasatinib
n=66 participants at risk
Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
|
|---|---|
|
General disorders
Chest pain
|
9.1%
6/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
General disorders
Fatigue
|
12.1%
8/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
5/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.6%
7/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Vascular disorders
Hypertension
|
10.6%
7/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
6/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Pharyngitis
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
13/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Constipation
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
6/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.6%
9/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Anaemia
|
30.3%
20/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
18/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Nervous system disorders
Headache
|
40.9%
27/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
General disorders
Pyrexia
|
15.2%
10/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Investigations
Weight increased
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
5/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
7/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.1%
8/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
11/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Sinusitis
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.8%
17/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
5/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Gastroenteritis
|
9.1%
6/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Psychiatric disorders
Insomnia
|
9.1%
6/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Gastrointestinal disorders
Nausea
|
21.2%
14/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.2%
14/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
General disorders
Peripheral swelling
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
8/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
General disorders
Asthenia
|
19.7%
13/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
12/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
10/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.1%
4/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.6%
5/66 • From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
All Treated Participants Study Initiated: September 14, 2011 Study Completion: January 26, 2016
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER