Trial Outcomes & Findings for A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders (NCT NCT02494258)
NCT ID: NCT02494258
Last Updated: 2026-04-02
Results Overview
A treatment emergent adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
From informed consent signed (Day 1) and until 28 days after the last dose of CC-486, or until the treatment discontinuation visit, whichever was later (up to approximately 90 months)
Results posted on
2026-04-02
Participant Flow
Participant milestones
| Measure |
CC-486 200 mg QD x 14 Days
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
CC-486 200 mg QD x 14 Days
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Overall Study
Progressive disease
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Other reasons
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders
Baseline characteristics by cohort
| Measure |
CC-486 200 mg QD x 14 Days
n=2 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: From informed consent signed (Day 1) and until 28 days after the last dose of CC-486, or until the treatment discontinuation visit, whichever was later (up to approximately 90 months)Population: All treated participants
A treatment emergent adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Outcome measures
| Measure |
CC-486 200 mg QD x 14 Days
n=2 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Treatment Emergent Drug-related SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Treatment Emergent Adverse Events
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Treatment Emergent Serious AEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)Population: All participants
Outcome measures
| Measure |
CC-486 200 mg QD x 14 Days
n=2 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
n=1 Participants
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Number of Participants Who Survived
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
CC-486 200 mg QD x 14 Days
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
CC-486 600 mg QD x 7 Days
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CC-486 500 mg QD x 7 Days
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
CC-486 200 mg QD x 7 Days
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CC-486 200 mg QD x 14 Days
n=2 participants at risk
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
Other adverse events
| Measure |
CC-486 200 mg QD x 14 Days
n=2 participants at risk
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 14 day dosing schedule.
|
CC-486 600 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 600 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 500 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 500 mg CC-486 tablet orally on a 7 day dosing schedule.
|
CC-486 200 mg QD x 7 Days
n=1 participants at risk
Participants with solid tumors and hematological disorders received 200 mg CC-486 tablet orally on a 7 day dosing schedule.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
General disorders and administration site conditions
Fatigue
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
General disorders and administration site conditions
Injection site erythema
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
General disorders and administration site conditions
Oedema peripheral
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Investigations
Heart rate irregular
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Nervous system disorders
Presyncope
|
50.0%
1/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
100.0%
1/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
0.00%
0/1 • Adverse Events and All cause mortality were collected from informed consent signed (Day 1) and date of death or last known documented date alive (up to approximately 90 months)
All participants
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
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