Trial Outcomes & Findings for Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (NCT NCT00867308)
NCT ID: NCT00867308
Last Updated: 2018-10-17
Results Overview
Number of participants with a complete or partial response according to International Working Group 2006 criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
15 weeks
Results posted on
2018-10-17
Participant Flow
2 participants on the 15mg arm and 3 participants on the 50mg arm were screen failures.
Participant milestones
| Measure |
Lenalidomide 15 mg
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
18
|
Reasons for withdrawal
| Measure |
Lenalidomide 15 mg
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
6
|
12
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lenalidomide 15 mg
n=9 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
n=18 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
20 Participants
n=27 Participants
|
|
Age, Continuous
|
77 years
n=9 Participants
|
70 years
n=18 Participants
|
72 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
22 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 15 weeksNumber of participants with a complete or partial response according to International Working Group 2006 criteria.
Outcome measures
| Measure |
Lenalidomide 15 mg
n=9 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
n=18 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Response Rate
Complete response
|
0 Participants
|
0 Participants
|
|
Response Rate
Partial response
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsNumber of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide.
Outcome measures
| Measure |
Lenalidomide 15 mg
n=9 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
n=18 Participants
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Grade 3-4 Toxicity
|
6 Participants
|
12 Participants
|
Adverse Events
Lenalidomide 15 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Lenalidomide 50 mg
Serious events: 9 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lenalidomide 15 mg
n=9 participants at risk
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
n=18 participants at risk
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Nervous system disorders
Weakness - leg
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Endocarditis
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Fungal pneumonia
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Meningitis
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Pericarditis
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
Other adverse events
| Measure |
Lenalidomide 15 mg
n=9 participants at risk
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
Lenalidomide 50 mg
n=18 participants at risk
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.
Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.
Patients without evidence of response after 4 cycles will be taken off-study.
|
|---|---|---|
|
Investigations
Anemia
|
22.2%
2/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
22.2%
4/18 • Number of events 4 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Blood and lymphatic system disorders
Bleeding
|
33.3%
3/9 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 5 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Blood and lymphatic system disorders
Bruising
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Nervous system disorders
Confusion
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
33.3%
6/18 • Number of events 8 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Cough
|
33.3%
3/9 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
22.2%
4/18 • Number of events 4 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
22.2%
4/18 • Number of events 7 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Cardiac disorders
Edema
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
38.9%
7/18 • Number of events 10 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Blood and lymphatic system disorders
Epistaxis
|
44.4%
4/9 • Number of events 5 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 5 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
44.4%
8/18 • Number of events 12 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
3/9 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Fever
|
11.1%
1/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Nervous system disorders
Hallucination
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Headache
|
11.1%
1/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Hoarseness
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Investigations
Hyperbilirubinemia
|
22.2%
2/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Investigations
Hypokalemia
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Investigations
Hyponatremia
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Investigations
Leukopenia
|
22.2%
2/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Cardiac disorders
Lightheadedness
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Myalgia
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
33.3%
6/18 • Number of events 11 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Pain - back
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Pain - chest
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
General disorders
Pain - tooth
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
44.4%
8/18 • Number of events 13 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • Number of events 5 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
33.3%
6/18 • Number of events 9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Investigations
Thrombocytopenia
|
33.3%
3/9 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
0.00%
0/18 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • Number of events 1 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
5.6%
1/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
16.7%
3/18 • Number of events 3 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Nervous system disorders
Weakness
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
33.3%
6/18 • Number of events 6 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
|
Gastrointestinal disorders
Xerostomia
|
0.00%
0/9 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
11.1%
2/18 • Number of events 2 • Up to 8 months
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place