Trial Outcomes & Findings for Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients (NCT NCT02400281)
NCT ID: NCT02400281
Last Updated: 2024-07-03
Results Overview
To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or MLFS. Death in aplasia response include deaths occurring following chemotherapy while cytopenic with an aplastic or hypoplastic BM prior to death without evidence of persistent leukemia.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline up to first documented response, persistent disease, or death (whichever occurs first), 1 year.
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
12
|
5
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
5
|
10
|
5
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Baseline characteristics by cohort
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
n=3 Participants
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
n=5 Participants
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
n=12 Participants
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
n=5 Participants
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
n=3 Participants
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
51 years
n=7 Participants
|
65 years
n=5 Participants
|
69 years
n=4 Participants
|
60 years
n=21 Participants
|
—
|
59.5 years
n=115 Participants
|
|
Age, Customized
18-60 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Age, Customized
>60 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
FLT3 Mutations
ITD only
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
FLT3 Mutations
TKD only
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
FLT3 Mutations
ITD and TKD
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Baseline ECOG Performance
0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Baseline ECOG Performance
1
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Baseline ECOG Performance
2
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Antecedent Hematological Disorder
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
10 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to first documented response, persistent disease, or death (whichever occurs first), 1 year.Population: Number of participants analyzed in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg Crenolanib) is zero as the study concluded prior to enrolling any participants on this arm.
To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or MLFS. Death in aplasia response include deaths occurring following chemotherapy while cytopenic with an aplastic or hypoplastic BM prior to death without evidence of persistent leukemia.
Outcome measures
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
n=3 Participants
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
n=5 Participants
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
n=12 Participants
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
n=5 Participants
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
n=3 Participants
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
|---|---|---|---|---|---|---|
|
Response Rate of Crenolanib Besylate Combination Therapy
CR/CRi
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate of Crenolanib Besylate Combination Therapy
MLFS
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Crenolanib Besylate Combination Therapy
ORR (CR/CRi+MLFS)
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate of Crenolanib Besylate Combination Therapy
Persistent Disease (PD)
|
1 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Response Rate of Crenolanib Besylate Combination Therapy
Death in Aplasia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
Serious events: 12 serious events
Other events: 12 other events
Deaths: 8 deaths
Crenolanib With 5-azacitidine - Dose Level 1
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Crenolanib With 5-azacitidine - Dose Level 2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Crenolanib With 5-azacitidine - Dose Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
n=3 participants at risk
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
n=5 participants at risk
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
n=12 participants at risk
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
n=5 participants at risk
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
n=3 participants at risk
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pseudomonas infection
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
Other adverse events
| Measure |
Crenolanib With Standard Salvage Chemotherapy - Dose Level 1
n=3 participants at risk
Patients received 60 mg TID (dose level 1) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 2
n=5 participants at risk
Patients received 80 mg TID (dose level 2) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With Standard Salvage Chemotherapy - Dose Level 3
n=12 participants at risk
Patients received 100 mg TID (dose level 3) crenolanib combined with standard salvage chemotherapy. Salvage chemotherapy options included IA (Idarubicin (Ida) 12 mg/m2 for 3 days (d) with cytarabine (AraC) 1.5 g/m2 for 4 days (3 d if age \> 60 yrs)), FLAG-Ida (Fludarabine 30 mg/m2, AraC 2g/m2 each for 5 days, and Ida 8 mg/m2 for 3 days) or MEC (Mitoxantrone 8 mg/m2, etoposide 100 mg/m2, AraC 1g/m2 all for 5 days). Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 1
n=5 participants at risk
Patients received 60 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 2
n=3 participants at risk
Patients received 80 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
Crenolanib With 5-azacitidine - Dose Level 3
Patients received 100 mg TID crenolanib combined with 5-azacitidine. 5-azacitidine was given at 75 mg/m2/day for 7 days each cycle. Patients were allowed to continue receiving crenolanib for up to 365 days after the completion of cytotoxic therapy if they remained in remission. Standard rolling-6 design was implemented with dose escalation of crenolanib as follows: 60 mg TID (dose level 1), 80 mg TID (dose level 2), and 100 mg TID (dose level 3). Crenolanib was given continuously starting at the end of chemotherapy, and discontinued 3 days before the next cycle.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
75.0%
9/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
41.7%
5/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Periorbital oedema
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Eye disorders
Vision impaired
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
41.7%
5/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
75.0%
9/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
50.0%
6/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Odonophagia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Chills
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Face oedema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
58.3%
7/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Local swelling
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Malaise
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
41.7%
5/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Pain
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Burkholderia infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Clostridium difficile colitis
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia bacterial
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Pseudomonas infection
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Trichosporon infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Eye injury
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Subdural hemorrhage
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Fluid overload
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Fluid retention
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
58.3%
7/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypoalbunaemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
8/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
58.3%
7/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
58.3%
7/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypomagnaesemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
8/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
100.0%
5/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
41.7%
5/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
80.0%
4/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Dysguesia
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Haemorrhage inctracranial
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
3/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
75.0%
9/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
4/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
60.0%
3/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia respiratory synctial viral
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Surgical and medical procedures
Micrographic skin surgery
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
16.7%
2/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
20.0%
1/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
25.0%
3/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
40.0%
2/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
1/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
8.3%
1/12 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/5 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
0.00%
0/3 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
—
0/0 • From date of first dose up to 30-days after the last dose, 1 year.
The number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero in the arm Crenolanib With 5-azacitidine - Dose Level 3 (100mg TID Crenolanib) as no patients were enrolled on this arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place