Trial Outcomes & Findings for Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus (NCT NCT01781975)

NCT ID: NCT01781975

Last Updated: 2020-02-11

Results Overview

The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term "AUC mean" comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose

Results posted on

2020-02-11

Participant Flow

Recruitment Period: March 2013 to May 2016 at 9 clinical sites (8 US, 1 Australia)

Participant milestones

Participant milestones
Measure	Imatinib Mesylate 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo Placebo given once daily basis. Placebo (For imatinib mesylate)
Overall Study STARTED	45	22
Overall Study Treatment Period	44	22
Overall Study Follow-Up Period	43	21
Overall Study COMPLETED	43	21
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Imatinib Mesylate 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo Placebo given once daily basis. Placebo (For imatinib mesylate)
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	22 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.2 years STANDARD_DEVIATION 7.2 • n=5 Participants	26.2 years STANDARD_DEVIATION 6.6 • n=7 Participants	27 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	10 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	19 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	21 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	18 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Australia	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Number of Autoantibodies Positive 1	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Number of Autoantibodies Positive 2	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Number of Autoantibodies Positive 3	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Number of Autoantibodies Positive 4	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Number of Autoantibodies Positive 5	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit	0.834 nmol/L Standard Deviation 0.446	0.775 nmol/L Standard Deviation 0.278

SECONDARY outcome

Timeframe: Visit 13 (Week 104)

Area under the MMTT-stimulated peak, 4 hour C-peptide AUC mean at week 104. The units are reported as nano-moles/Liter because this is AUC mean (the AUC is divided by the time internal so that the units return to the c-peptide units of measure).

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months	0.472 nmol/L Interval 0.355 to 0.599	0.389 nmol/L Interval 0.255 to 0.538

SECONDARY outcome

Timeframe: Visit 9 (Week 52) and Visit 13 (Week 104)

Change in HbA1c levels from Week 52 to Week 104

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Change in HbA1c Levels Over Time Week 52	6.33 percentage of HbA1c level Interval 6.02 to 6.66	6.51 percentage of HbA1c level Interval 6.03 to 7.02
Change in HbA1c Levels Over Time Week 104	6.44 percentage of HbA1c level Interval 6.09 to 6.81	7.03 percentage of HbA1c level Interval 6.42 to 7.69

SECONDARY outcome

Timeframe: Visit 9 (Week 52) and Visit 13 (Week 104)

Assess insulin use in units per kilogram body weight per day at weeks 52 and 104.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Change in Insulin Dose (Units/kg) Over Time Week 52	0.307 Units per Kg Interval 0.24 to 0.379	0.413 Units per Kg Interval 0.279 to 0.56
Change in Insulin Dose (Units/kg) Over Time Week 104	0.389 Units per Kg Interval 0.315 to 0.467	0.488 Units per Kg Interval 0.353 to 0.637

SECONDARY outcome

Timeframe: Visit 0 (Week 0), Visit 9 (Week 52), and Visit 13 (Week 104)

Major hypoglycemic events occurring from randomization at weeks 0, 52 and 104.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Number of Severe Hypoglycemic Events	2 events	3 events

SECONDARY outcome

Timeframe: Adverse Events will be assessed at Visit 0 (week 0), Visit 1 (Week 2), Visit 2 (Week 4), and every month thereafter.

Number of adverse events that were reported throughout the study.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=45 Participants 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 Participants Placebo given once daily basis. Placebo (For imatinib mesylate)
Number of Adverse Events	172 events	28 events

Adverse Events

Imatinib Mesylate

Serious events: 8 serious events

Other events: 23 other events

Deaths: 1 deaths

Placebo

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Melissa Parker

University of South Florida

Phone: 8133969378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Imatinib Mesylate n=45 participants at risk 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 participants at risk Placebo given once daily basis. Placebo (For imatinib mesylate)
Metabolism and nutrition disorders Hypoglycemia	4.4% 2/45 • Number of events 3 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Pregnancy, puerperium and perinatal conditions Fluid in Lungs	0.00% 0/45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Endocrine disorders Diabetes ketoacidosis	0.00% 0/45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Psychiatric disorders Suicide Attempt	2.2% 1/45 • Number of events 3 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Skin and subcutaneous tissue disorders Folliculitis	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Respiratory, thoracic and mediastinal disorders Wheezing	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Psychiatric disorders Anxiety	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Respiratory, thoracic and mediastinal disorders Respiratory - Other	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Musculoskeletal and connective tissue disorders Myalgia	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Skin and subcutaneous tissue disorders Prutitus	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Cardiac disorders Wolff-Parkinson-White Syndrome	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Investigations Aspartate Aminotransferase Increased	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Skin and subcutaneous tissue disorders Rash maculo papular	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Infections and infestations Axillary Abscess	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.

Measure	Imatinib Mesylate n=45 participants at risk 400 mg imatinib given once daily basis. Imatinib Mesylate	Placebo n=22 participants at risk Placebo given once daily basis. Placebo (For imatinib mesylate)
Infections and infestations Infections and infestations	26.7% 12/45 • Number of events 26 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	18.2% 4/22 • Number of events 9 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Eye disorders Eye disorders	4.4% 2/45 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	6.7% 3/45 • Number of events 4 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Nervous system disorders Nervous system disorders	8.9% 4/45 • Number of events 4 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Gastrointestinal disorders Gastrointestinal disorders	13.3% 6/45 • Number of events 13 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Metabolism and nutrition disorders Metabolism and nutrition disorders	11.1% 5/45 • Number of events 11 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	9.1% 2/22 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Reproductive system and breast disorders Reproductive system and breast disorders	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Psychiatric disorders Psychiatric disorders	11.1% 5/45 • Number of events 9 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	13.3% 6/45 • Number of events 6 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	11.1% 5/45 • Number of events 6 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	9.1% 2/22 • Number of events 3 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Ear and labyrinth disorders Ear and labyrinth disorders	2.2% 1/45 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Cardiac disorders Cardiac disorders	8.9% 4/45 • Number of events 6 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
General disorders General disorders & administration site condt'ns	4.4% 2/45 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Investigations Investigations	22.2% 10/45 • Number of events 18 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	9.1% 2/22 • Number of events 4 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions	0.00% 0/45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	4.4% 2/45 • Number of events 4 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Immune system disorders Immune system disorders	0.00% 0/45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 1 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Hepatobiliary disorders Hepatobiliary disorders	6.7% 3/45 • Number of events 5 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	9.1% 2/22 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Blood and lymphatic system disorders Blood and lymphatic system disorders	8.9% 4/45 • Number of events 7 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Endocrine disorders Endocrine disorders	8.9% 4/45 • Number of events 45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	4.5% 1/22 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Surgical and medical procedures Surgical and medical procedures	0.00% 0/45 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	9.1% 2/22 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.
Renal and urinary disorders Renal and urinary disorders	2.2% 1/45 • Number of events 2 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.	0.00% 0/22 • 2 years Adverse events that were not considered Serious Adverse Events (SAE) were monitored/assessed without regard to the specific Adverse Event Term so the categories they belong to are provided below.