Trial Outcomes & Findings for Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations (NCT NCT01522469)

Last Updated: 2024-01-30

Results Overview

To determine the response rate to crenolanib.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. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but \>5%. Hematologic improvement (HI) response included erythroid response where Hgb increased ≥ 1.5 g/dL, platelet response where platelets increased ≥ 30 x 10\^9/L for patient starting with \>20 x 10\^9/L platelets or increase from \<20 x 10\^9/L to \>20 x 10\^9/L and by at least 100% and neutrophil response where at least 100% increase and an increase \>0.5 x 10\^9/L. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or HI.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From the date of first dose to the end of protocol treatment, 1 year.

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	TKI Pre-treated Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have a history of prior therapy with one or more FLT3 TKIs received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.	TKI Naive Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Overall Study STARTED	9	4
Overall Study COMPLETED	9	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TKI Pre-treated n=9 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have a history of prior therapy with one or more FLT3 TKIs received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.	TKI Naive n=4 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.	Total n=13 Participants Total of all reporting groups
Age, Customized 18 to 44 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 45 to 60 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized Greater than 60 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
FLT3 status FLT3-ITD	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
FLT3 status FLT3-D835	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
FLT3 status FLT3-ITD and D835	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Number of prior therapies	3 number of lines of therapy n=5 Participants	1.5 number of lines of therapy n=7 Participants	2 number of lines of therapy n=5 Participants
Baseline ECOG Performance ECOG 0	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline ECOG Performance ECOG 1	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Baseline ECOG Performance ECOG 2	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of first dose to the end of protocol treatment, 1 year.

Outcome measures

Outcome measures
Measure	All Patients n=13 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.	TKI Pre-treated n=9 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have a history of prior therapy with one or more FLT3 TKIs received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.	TKI Naive n=4 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Overall Response Rate CR/CRi	5 Participants	2 Participants	3 Participants
Overall Response Rate PR	1 Participants	1 Participants	0 Participants
Overall Response Rate HI	3 Participants	2 Participants	1 Participants
Overall Response Rate ORR (CR+PR)	6 Participants	3 Participants	3 Participants
Overall Response Rate Clinical Benefit (CR+PR+HI)	9 Participants	5 Participants	4 Participants
Overall Response Rate RD	4 Participants	4 Participants	0 Participants

Adverse Events

All Patients

Serious events: 12 serious events

Other events: 13 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Blood and lymphatic system disorders Febrile neutropenia	61.5% 8/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Pancytopenia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Cardiac failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Tachycardia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Vomiting	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Gastrointestinal haemorrhage	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Nausea	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Retroperitoneal haemorrhage	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Gastritis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Haematemesis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Disease progression	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Multiple organ dysfunction syndrome	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Multi-organ failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Mucosal inflammation	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Pyrexia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Sepsis	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Pneumonia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Influenza	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Clostridium difficile infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Cellulitis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Liver function test increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood bilirubin increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Metabolic acidosis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Headache	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Cerebral infarction	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Lung infiltration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Tachypnoea	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.

Other adverse events

Other adverse events
Measure	All Patients n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Infections and infestations Bacteremia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Cellulitis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Conjunctivitis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Febrile neutropenia	69.2% 9/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Anemia	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Pancytopenia	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Disseminated intravascular coagulation	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Leukopenia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Blood and lymphatic system disorders Thrombocytopenia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Tachycardia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Cardiomegaly	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Cardiac failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Cardiac disorders Sinus tachycardia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Endocrine disorders Hypothyroidism	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Eye disorders Ocular icterus	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Eye disorders Retinal hemorrhage	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Eye disorders Vitreous hemorrhage	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Vomiting	92.3% 12/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Diarrhea	84.6% 11/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Nausea	84.6% 11/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Abdominal pain	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Gastrointestinal hemorrhage	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Stomatitis	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Constipation	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Abdominal pain lower	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Flatulence	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Hematemesis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Hemorrhoids	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Hiatus hernia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Ileus paralytic	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Lip ulceration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Mouth ulceration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Oral mucosal blistering	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Retching	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Small intestinal obstruction	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Tongue ulceration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Umbilical hernia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Fatigue	61.5% 8/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Oedema peripheral	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Chest pain	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Chills	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Disease progression	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Face oedema	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Multiple organ dysfunction syndrome	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Oedema	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Pain	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Pyrexia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Asthenia	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Malaise	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
General disorders Multi-organ disorder	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Hepatobiliary disorders Hepatomegaly	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Sepsis	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Clostridium difficile infection	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Pneumonia	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Alpha hemolytic streptococcal infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Endocarditis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Influenza	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Lung infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Oral candidiasis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Oral herpes	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Respiratory synctial virus infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Staphlococcal infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Injury, poisoning and procedural complications Contusion	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Injury, poisoning and procedural complications Arthropod bite	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Injury, poisoning and procedural complications Procedural complication	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Injury, poisoning and procedural complications Procedural pain	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Platelet count decreased	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Alanine aminotransferase increased	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Lymphocyte count decreased	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations White blood cell count decreased	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Aspartate aminotransferase increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood alkaline phosphatase increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood bilirubin increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood lactate dehydrogenase increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood phosphorus increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Neutrophil count decreased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Weight decreased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Weight increased	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood albumin decreased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood glucose increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood urea increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood urea nitrogen/creatinine ratio	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Blood urea nitrogen/creatinine ratio increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Cardiac murmur	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Gamma-glutamyl transferase increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Liver function test increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Lymphocyte count increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations Monocyte count decreased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Investigations White blood cell count increased	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Decreased appetite	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypocalcemia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypokalemia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hyponatremia	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypoalbuminemia	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Abnormal loss of weight	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Fluid overload	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hyperglycemia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypervolemia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Hypoproteinemia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Metabolism and nutrition disorders Metabolic acidosis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Bone pain	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Joint swelling	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Headache	30.8% 4/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Neuropathy peripheral	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Hypoesthesia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Paresthesia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Nervous system disorders Syncope	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Psychiatric disorders Anxiety	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Psychiatric disorders Depression	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Psychiatric disorders Insomnia	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Psychiatric disorders Sleep disorder	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Psychiatric disorders Hallucination	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Renal and urinary disorders Acute kidney injury	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Renal and urinary disorders Hematuria	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Renal and urinary disorders Pollakiuria	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Reproductive system and breast disorders Menorrhagia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Reproductive system and breast disorders Vaginal oedema	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Reproductive system and breast disorders Vulval disorder	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Cough	38.5% 5/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Nasal congestion	23.1% 3/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Tachypnoea	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Erythema	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Hair color changes	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Madarosis	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Night sweats	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Petechiae	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Purpura	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Skin lesion	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Skin and subcutaneous tissue disorders Urticaria	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Vascular disorders Hypotension	15.4% 2/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Vascular disorders Hypertension	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Lung infiltration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 1/13 • From date of first dose up to 30-days after the last dose, 1 year. Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.

Additional Information

Edward McDonald

Arog Pharmaceuticals

Phone: 214-593-0500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place