Trial Outcomes & Findings for A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations (NCT NCT01657682)

NCT ID: NCT01657682

Last Updated: 2023-11-30

Results Overview

To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Blast reduction (BR) response included a decrease of ≥50% in % blasts. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or MLFS.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: From the date of first dose to the end of protocol treatment.
• Results posted on: 2023-11-30

Participant Flow

A total of 56 participants who met all inclusion criteria and none of the exclusion criteria were included in the study and were enrolled at 1 center in the United States.

Participant milestones

Measure	Cohort A - No Prior FLT3 TKI Exposure Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Overall Study STARTED	13	30	13
Overall Study COMPLETED	12	28	12
Overall Study NOT COMPLETED	1	2	1

Reasons for withdrawal

Measure	Cohort A - No Prior FLT3 TKI Exposure Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	0	1	1
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Race data was not available for one patient in cohort B.

Baseline characteristics by cohort

Measure	Cohort A - No Prior FLT3 TKI Exposure n=13 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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=30 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder n=13 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.	Total n=56 Participants Total of all reporting groups
Age, Customized Between 18 and 44 years	2 Participants n=13 Participants	7 Participants n=30 Participants	2 Participants n=13 Participants	11 Participants n=56 Participants
Age, Customized Between 45 and 60 years	4 Participants n=13 Participants	8 Participants n=30 Participants	3 Participants n=13 Participants	15 Participants n=56 Participants
Age, Customized >60 years	7 Participants n=13 Participants	15 Participants n=30 Participants	8 Participants n=13 Participants	30 Participants n=56 Participants
Sex: Female, Male Female	8 Participants n=13 Participants	15 Participants n=30 Participants	7 Participants n=13 Participants	30 Participants n=56 Participants
Sex: Female, Male Male	5 Participants n=13 Participants	15 Participants n=30 Participants	6 Participants n=13 Participants	26 Participants n=56 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=13 Participants • Race data was not available for one patient in cohort B.	2 Participants n=29 Participants • Race data was not available for one patient in cohort B.	1 Participants n=13 Participants • Race data was not available for one patient in cohort B.	3 Participants n=55 Participants • Race data was not available for one patient in cohort B.
Race/Ethnicity, Customized Race · Asian	1 Participants n=13 Participants • Race data was not available for one patient in cohort B.	5 Participants n=29 Participants • Race data was not available for one patient in cohort B.	1 Participants n=13 Participants • Race data was not available for one patient in cohort B.	7 Participants n=55 Participants • Race data was not available for one patient in cohort B.
Race/Ethnicity, Customized Race · White	11 Participants n=13 Participants • Race data was not available for one patient in cohort B.	18 Participants n=29 Participants • Race data was not available for one patient in cohort B.	11 Participants n=13 Participants • Race data was not available for one patient in cohort B.	40 Participants n=55 Participants • Race data was not available for one patient in cohort B.
Race/Ethnicity, Customized Race · Other	1 Participants n=13 Participants • Race data was not available for one patient in cohort B.	4 Participants n=29 Participants • Race data was not available for one patient in cohort B.	0 Participants n=13 Participants • Race data was not available for one patient in cohort B.	5 Participants n=55 Participants • Race data was not available for one patient in cohort B.
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	1 Participants n=13 Participants	4 Participants n=30 Participants	0 Participants n=13 Participants	5 Participants n=56 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	12 Participants n=13 Participants	25 Participants n=30 Participants	13 Participants n=13 Participants	50 Participants n=56 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	0 Participants n=13 Participants	1 Participants n=30 Participants	0 Participants n=13 Participants	1 Participants n=56 Participants
Baseline FLT3 mutation FLT3-ITD only	8 Participants n=13 Participants	15 Participants n=30 Participants	3 Participants n=13 Participants	26 Participants n=56 Participants
Baseline FLT3 mutation FLT3-TKD only	5 Participants n=13 Participants	2 Participants n=30 Participants	4 Participants n=13 Participants	11 Participants n=56 Participants
Baseline FLT3 mutation FLT3-ITD and FLT3-TKD	0 Participants n=13 Participants	13 Participants n=30 Participants	6 Participants n=13 Participants	19 Participants n=56 Participants
Baseline ECOG Performance 0 - Normal activity	2 Participants n=13 Participants	3 Participants n=30 Participants	1 Participants n=13 Participants	6 Participants n=56 Participants
Baseline ECOG Performance 1 - Symptoms but ambulatory	9 Participants n=13 Participants	21 Participants n=30 Participants	9 Participants n=13 Participants	39 Participants n=56 Participants
Baseline ECOG Performance 2 - In bed < 50% of time	2 Participants n=13 Participants	6 Participants n=30 Participants	3 Participants n=13 Participants	11 Participants n=56 Participants
Number of Prior Therapies	2 prior therapies n=13 Participants	3 prior therapies n=30 Participants	2 prior therapies n=13 Participants	3 prior therapies n=56 Participants

PRIMARY outcome

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

To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Blast reduction (BR) response included a decrease of ≥50% in % blasts. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or MLFS.

Outcome measures

Measure	All Patients n=56 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort A - No Prior FLT3 TKI Exposure n=13 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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=30 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder n=13 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Response Rate of Patients Receiving Crenolanib Therapy CR/CRi	8 Participants	3 Participants	4 Participants	1 Participants
Response Rate of Patients Receiving Crenolanib Therapy PR	9 Participants	2 Participants	5 Participants	2 Participants
Response Rate of Patients Receiving Crenolanib Therapy ORR (CR+PR)	17 Participants	5 Participants	9 Participants	3 Participants
Response Rate of Patients Receiving Crenolanib Therapy BR	21 Participants	5 Participants	11 Participants	5 Participants
Response Rate of Patients Receiving Crenolanib Therapy Clinical Benefit (CR+PR+BR)	38 Participants	10 Participants	20 Participants	8 Participants
Response Rate of Patients Receiving Crenolanib Therapy Resistant disease (RD)	18 Participants	3 Participants	10 Participants	5 Participants

SECONDARY outcome

Timeframe: From the date of first dose up to end of treatment, up to 24 months.

To determine the overall survival of AML patients with activating FLT3 mutations treated with crenolanib

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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort A - No Prior FLT3 TKI Exposure n=30 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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=13 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Duration of Overall Survival	237 days Interval 134.0 to 548.0	100 days Interval 76.0 to 192.0	85 days Interval 49.0 to 329.0	—

SECONDARY outcome

Timeframe: Defined as the duration from first day to the last dose, up to 24 months, interruptions in study drug administration were not counted.

To determine the study drug exposure of relapse/refractory AML patients receiving 100 mg crenolanib besylate tablets three times daily.

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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort A - No Prior FLT3 TKI Exposure n=30 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 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=13 Participants Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Study Drug Exposure	57 days Interval 16.0 to 139.0	43.5 days Interval 5.0 to 197.0	50 days Interval 10.0 to 138.0	—

Adverse Events

All Patients

Serious events: 52 serious events

Other events: 56 other events

Deaths: 53 deaths

Cohort A - No Prior FLT3 TKI Exposure

Serious events: 10 serious events

Other events: 13 other events

Deaths: 12 deaths

Cohort B - Prior Therapy With FLT3 TKI

Serious events: 30 serious events

Other events: 30 other events

Deaths: 29 deaths

Cohort C - Antecedent Hematological Disorder

Serious events: 12 serious events

Other events: 13 other events

Deaths: 12 deaths

Serious adverse events

Measure	All Patients n=56 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort A - No Prior FLT3 TKI Exposure n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=30 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Injury, poisoning and procedural complications Subdural hematoma	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Fall	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Transfusion reaction	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Hip fracture	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Alanine aminotransferase increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Aspartate aminotransferase increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood bilirubin increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Transaminases increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Weight increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypokalemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Acidosis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Dehydration	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Anemia	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Febrile neutropenia	26.8% 15/56 • From the date of first dose up to end of treatment, up to 24 months.	30.8% 4/13 • From the date of first dose up to end of treatment, up to 24 months.	26.7% 8/30 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Acute coronary syndrome	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Leukocytosis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Atrial fibrillation	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Atrial flutter	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Tachycardia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Cardiac arrest	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Pericardial effusion	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Supraventricular tachycardia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Ventricular extrasystoles	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastric hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Proctalgia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Abdominal pain	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Diarrhea	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastritis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastrointestinal hemorrhage	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Nausea	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Parotitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Vomiting	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Mouth hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Pancreatitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Rectal hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Death	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Disease progression	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	16.7% 5/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Mucosal inflammation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Asthenia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Fatigue	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Generalized edema	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Multi-organ failure	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Multiple organ dysfunction syndrome	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Non-cardiac chest pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Edema peripheral	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Pyrexia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Cellulitis	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Medical device site joint infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pneumonia	32.1% 18/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	30.0% 9/30 • From the date of first dose up to end of treatment, up to 24 months.	53.8% 7/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pneumonia fungal	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Urinary tract infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations BK virus infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Cytomegalovirus viremia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Enterococcal infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Escherichia sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Oral infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Periorbital cellulitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pseudomonal sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Septic shock	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Sinusitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Skin infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Soft tissue infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Stenotrophomonas sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Hepatobiliary disorders Portal vein thrombosis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Immune system disorders Hypersensitivity	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Hepatobiliary disorders Cholecystitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyponatremia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Tumor lysis syndrome	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Syncope	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Hemorrhage intracranial	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Headache	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Seizure	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Muscular weakness	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Neck pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Confusional state	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Mental status changes	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Acute kidney injury	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Cystitis hemorrhagic	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Anorectal cellulitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Hemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Hypotension	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Hypertension	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Embolism	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Periorbital oedema	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Decreased appetite	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.

Other adverse events

Measure	All Patients n=56 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort A - No Prior FLT3 TKI Exposure n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort B - Prior Therapy With FLT3 TKI n=30 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of prior therapy with one or more FLT3 TKIs received 100 mg crenolanib besylate tablets administered orally three times a day.	Cohort C - Antecedent Hematological Disorder n=13 participants at risk Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have history of antecedent hematological disorder received 100 mg crenolanib besylate tablets administered orally three times a day.
Blood and lymphatic system disorders Anaemia	19.6% 11/56 • From the date of first dose up to end of treatment, up to 24 months.	30.8% 4/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Bone marrow failure	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Coagulopathy	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Febrile neutropenia	30.4% 17/56 • From the date of first dose up to end of treatment, up to 24 months.	30.8% 4/13 • From the date of first dose up to end of treatment, up to 24 months.	26.7% 8/30 • From the date of first dose up to end of treatment, up to 24 months.	38.5% 5/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Haemolysis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Histiocytosis haematophagic	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Hypofibrinogenaemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Leukocytosis	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Splenomegaly	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Blood and lymphatic system disorders Thrombocytopenia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Acute coronary syndrome	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Atrial fibrillation	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Atrial flutter	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Cardiac arrest	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Left ventricular dysfunction	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Pericardial effusion	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	16.7% 5/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Sinus tachycardia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Supraventricular tachycardia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Tachycardia	12.5% 7/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Cardiac disorders Ventricular extrasystoles	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Ear and labyrinth disorders Deafness	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Ear and labyrinth disorders Ear pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Ear and labyrinth disorders Excessive cerumen production	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Ear and labyrinth disorders Hearing impaired	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Endocrine disorders Cushingoid	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Conjunctival haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Diplopia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Erythema of eyelid	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Eye discharge	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Periorbital oedema	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Pupils unequal	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Vision blurred	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Eye disorders Vitreous haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Abdominal discomfort	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Abdominal distension	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Abdominal pain	14.3% 8/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Abdominal pain upper	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Constipation	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Diarrhoea	57.1% 32/56 • From the date of first dose up to end of treatment, up to 24 months.	53.8% 7/13 • From the date of first dose up to end of treatment, up to 24 months.	50.0% 15/30 • From the date of first dose up to end of treatment, up to 24 months.	76.9% 10/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Dry mouth	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Duodenitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Asthenia	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Chest pain	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Chills	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Death	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Disease progression	12.5% 7/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	16.7% 5/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Face oedema	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Fatigue	44.6% 25/56 • From the date of first dose up to end of treatment, up to 24 months.	38.5% 5/13 • From the date of first dose up to end of treatment, up to 24 months.	43.3% 13/30 • From the date of first dose up to end of treatment, up to 24 months.	53.8% 7/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Gait disturbance	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Generalised oedema	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Inflammation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Localised oedema	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Mucosal inflammation	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Multi-organ failure	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Multiple organ dysfunction syndrome	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Nodule	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Oedema	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Oedema mucosal	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Oedema peripheral	39.3% 22/56 • From the date of first dose up to end of treatment, up to 24 months.	38.5% 5/13 • From the date of first dose up to end of treatment, up to 24 months.	36.7% 11/30 • From the date of first dose up to end of treatment, up to 24 months.	46.2% 6/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Pain	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Peripheral swelling	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
General disorders Pyrexia	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Dyspepsia	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Dysphagia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Epigastric discomfort	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Faeces discoloured	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastric haemorrhage	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastritis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gastrointestinal haemorrhage	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gingival bleeding	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Gingival pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Haematemesis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Haematochezia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Haemorrhoids	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Lip dry	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Lip exfoliation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Lip swelling	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Melaena	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Mouth haemorrhage	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Mouth ulceration	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Nausea	78.6% 44/56 • From the date of first dose up to end of treatment, up to 24 months.	84.6% 11/13 • From the date of first dose up to end of treatment, up to 24 months.	73.3% 22/30 • From the date of first dose up to end of treatment, up to 24 months.	84.6% 11/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Oesophageal pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Oral mucosal blistering	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Oral pain	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Pancreatitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Parotitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Proctalgia	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Rectal haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Stomatitis	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Toothache	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Gastrointestinal disorders Vomiting	50.0% 28/56 • From the date of first dose up to end of treatment, up to 24 months.	53.8% 7/13 • From the date of first dose up to end of treatment, up to 24 months.	53.3% 16/30 • From the date of first dose up to end of treatment, up to 24 months.	38.5% 5/13 • From the date of first dose up to end of treatment, up to 24 months.
Hepatobiliary disorders Cholecystitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Hepatobiliary disorders Hyperbilirubinaemia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Immune system disorders Graft versus host disease	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Immune system disorders Graft versus host disease in skin	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Immune system disorders Hypersensitivity	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations BK virus infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Bronchitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Cellulitis	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Clostridium difficile colitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Clostridium difficile infection	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Enterococcal infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Escherichia sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Eye infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Gingivitis	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Localised infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Lung infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Medical device site joint infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Mucosal infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Oral candidiasis	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Oral infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Parotitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Periorbital cellulitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pneumonia	37.5% 21/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	36.7% 11/30 • From the date of first dose up to end of treatment, up to 24 months.	61.5% 8/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pneumonia fungal	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Post procedural cellulitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Pseudomonal sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Rash pustular	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Septic shock	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Skin infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Soft tissue infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Staphylococcal bacteraemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Stenotrophomonas sepsis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Streptococcal bacteraemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Upper respiratory tract infection	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Infections and infestations Urinary tract infection	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Allergic transfusion reaction	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Contusion	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Face injury	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Fall	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Head injury	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Hip fracture	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Ligament sprain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Subdural haematoma	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Injury, poisoning and procedural complications Transfusion reaction	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Alanine aminotransferase	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Alanine aminotransferase increased	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Amylase increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Aspartate aminotransferase	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Aspartate aminotransferase increased	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood alkaline phosphatase increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood bilirubin	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood bilirubin increased	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood creatinine	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood creatinine increased	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Blood phosphorus increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Cardiac murmur	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Electrocardiogram QT prolonged	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Gamma-glutamyltransferase	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Lipase increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Oxygen saturation decreased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Pancreatic enzymes increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Platelet count decreased	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Transaminases increased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Weight decreased	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations Weight increased	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations White blood cell count decreased	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Investigations White blood cell count increased	12.5% 7/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Acidosis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Decreased appetite	21.4% 12/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	38.5% 5/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Dehydration	12.5% 7/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Fluid overload	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Fluid retention	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypercalcaemia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyperglycaemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyperkalaemia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypermagnesaemia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypernatraemia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyperphosphataemia	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyperuricaemia	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypocalcaemia	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypokalaemia	21.4% 12/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	16.7% 5/30 • From the date of first dose up to end of treatment, up to 24 months.	30.8% 4/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hypomagnesaemia	16.1% 9/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Hyponatraemia	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Iron overload	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Metabolic acidosis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Metabolism and nutrition disorders Tumour lysis syndrome	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Arthritis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Back pain	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Bone pain	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Muscle tightness	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Muscular weakness	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Myalgia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Cerebellar ataxia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Dizziness	12.5% 7/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Dysgeusia	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Dystonia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Haemorrhage intracranial	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Headache	14.3% 8/56 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Lethargy	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Myoclonus	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Poor quality sleep	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Seizure	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Somnolence	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Syncope	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	30.8% 4/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Tremor	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Adjustment disorder	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Anxiety	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Claustrophobia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Confusional state	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Depression	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Hallucination	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Insomnia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Psychiatric disorders Mental status changes	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Acute kidney injury	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Bladder dilatation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Bladder pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Bladder spasm	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Cystitis haemorrhagic	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Dysuria	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Renal and urinary disorders Haematuria	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Reproductive system and breast disorders Menorrhagia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Reproductive system and breast disorders Nipple pain	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Reproductive system and breast disorders Testicular swelling	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Cough	16.1% 9/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	20.0% 6/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Diaphragmalgia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.4% 12/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	23.3% 7/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	21.4% 12/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	26.7% 8/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.4% 3/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Hiccups	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Lung infiltration	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.0% 14/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	33.3% 10/30 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Productive cough	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Sinus congestion	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Tachypnoea	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Tracheal oedema	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Respiratory, thoracic and mediastinal disorders Wheezing	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Anorectal cellulitis	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Ecchymosis	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Erythema	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Ingrowing nail	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Nail discolouration	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Petechiae	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Pruritus	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Rash	8.9% 5/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Rash follicular	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Rash generalised	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Rash macular	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 4/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	13.3% 4/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Skin exfoliation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Skin irritation	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Skin lesion	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Skin mass	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	3.3% 1/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Swelling face	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Skin and subcutaneous tissue disorders Urticaria	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	6.7% 2/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Embolism	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Haemorrhage	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Hypertension	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Vascular disorders Hypotension	10.7% 6/56 • From the date of first dose up to end of treatment, up to 24 months.	23.1% 3/13 • From the date of first dose up to end of treatment, up to 24 months.	10.0% 3/30 • From the date of first dose up to end of treatment, up to 24 months.	15.4% 2/13 • From the date of first dose up to end of treatment, up to 24 months.
Nervous system disorders Paraesthenia	3.6% 2/56 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.
Musculoskeletal and connective tissue disorders Osteopenia	1.8% 1/56 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/13 • From the date of first dose up to end of treatment, up to 24 months.	0.00% 0/30 • From the date of first dose up to end of treatment, up to 24 months.	7.7% 1/13 • From the date of first dose up to end of treatment, up to 24 months.

Additional Information

Edward McDonald

Arog Pharmaceuticals

Phone: 214-593-0500

Email: emcdonald@arogpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place