Trial Outcomes & Findings for A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status (NCT NCT00462761)

NCT ID: NCT00462761

Last Updated: 2020-05-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline up to 30 days post last dose
• Results posted on: 2020-05-11

Participant Flow

A total of 76 participants who met all inclusion and no exclusion criteria were enrolled and treated in the study at 4 clinical sites in the United States and 2 sites in the Republic of Georgia.

Participant milestones

Measure	Quizartinib Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.
Overall Study STARTED	76
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	76

Reasons for withdrawal

Measure	Quizartinib Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.
Overall Study Adverse Event	6
Overall Study Withdrawal by Subject	9
Overall Study Physician Decision	5
Overall Study Disease progression	43
Overall Study Death	12
Overall Study Other	1

Baseline Characteristics

A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status

Baseline characteristics by cohort

Measure	Quizartinib n=76 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.
Age, Continuous	56.0 years STANDARD_DEVIATION 17.1 • n=5 Participants
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18 to 60 years	39 Participants n=5 Participants
Age, Customized 61 to 75 years	31 Participants n=5 Participants
Age, Customized >75 years	6 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose

Population: Safety events were assessed in the Safety Population.

Outcome measures

Measure	Quizartinib n=76 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Vomiting	8 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Abdominal pain	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Abdominal pain upper	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dyspepsia	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Constipation	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Abdominal distension	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Gastrointestinal haemorrhage	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Gastrooesophageal reflux disease	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Abdominal discomfort	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Oral mucosal blistering	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Epigastric discomfort	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Retching	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Respiratory, Thoracic, and Mediastinal Disorders	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Haemoptysis	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dyspnoea exertional	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Blood and Lymphatic System Disorders	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anaemia	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Thrombocytopenia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pancytopenia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Skin and Subcutaneous Tissue Disorders	8 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Periorbital odema	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Swelling face	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Alopecia	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dry skin	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Increased tendency to bruise	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hair colour changes	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hidradenitis	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Photosensitivity reaction	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Infections and Infestations	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pneumonia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Lung infection	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Metabolism and Nutrition Disorders	7 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypokalaemia	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anorexia	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hyperglycaemia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypoalbuminaemia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nervous System Disorders	12 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Headache	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dizziness	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dysgeusia	8 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypoaesthesia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Neuropathy peripheral	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dysarthria	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Contusion	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia At Least 1 Treatment-Related Adverse Event	39 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia General disorders & administration site conditions	11 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pyrexia	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Fatigue	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Oedema peripheral	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Asthenia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Chills	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Malaise	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Gastrointestinal disorders	21 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nausea	12 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Diarrhoea	6 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Investigations	11 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Electrocardiogram QT prolonged	9 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Blood bilirubin increased	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hepatic enzyme increased	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Psychiatric Disorders	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Insomnia	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Cardiac Disorders	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Right ventricular dysfunction	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Injury, Poisoning, and Procedural Complications	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Eye Disorders	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Eyelid oedema	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hepatobiliary Disorders	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hyperbilirubinaemia	3 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Jaundice	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose

Population: Safety events were assessed in the Safety Population.

Outcome measures

Measure	Quizartinib n=35 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID n=16 Participants Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD n=25 Participants Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total n=76 Participants All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nausea : All Grades	6 Participants	3 Participants	3 Participants	12 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Vomiting : Grade 3-4	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pyrexia : Grade 3-4	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Eyelid oedema : All Grades	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nausea : Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Electrocardiogram QT prolonged : All Grades	1 Participants	0 Participants	8 Participants	9 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Electrocardiogram QT prolonged : Grade 3-4	0 Participants	0 Participants	4 Participants	4 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dysgeusia : All Grades	4 Participants	1 Participants	3 Participants	8 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Dysgeusia : Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Vomiting : All Grades	3 Participants	3 Participants	2 Participants	8 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anorexia : All Grades	3 Participants	1 Participants	1 Participants	5 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anorexia : Grade 3-4	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Fatigue : All Grades	2 Participants	1 Participants	1 Participants	4 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Fatigue : Grade 3-4	1 Participants	0 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anaemia : All Grades	2 Participants	1 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Anaemia : Grade 3-4	2 Participants	1 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypokalaemia : All Grades	2 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypokalaemia : Grade 3-4	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pyrexia : All Grades	2 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Eyelid oedema : Grade 3-4	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypoalbuminaemia : All Grades	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hypoalbuminaemia : Grade 3-4	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Lung infection : All Grades	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Lung infection : Grade 3-4	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pancytopenia : All Grades	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Pancytopenia : Grade 3-4	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Photosensitivity reaction : All Grades	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Photosensitivity reaction : Grade 3-4	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Thrombocytopenia : All Grades	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Thrombocytopenia : Grade 3-4	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last dose, up to approximately 3 years

Population: Disease response was assessed in the Intent-to-Treat Population.

Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.

Outcome measures

Measure	Quizartinib n=3 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID n=8 Participants Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD n=6 Participants Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total n=5 Participants All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID n=5 Participants Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=3 Participants Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=5 Participants Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=6 Participants Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 Participants Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=6 Participants Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=17 Participants Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=8 Participants Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants n=76 Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia	2 Participants	2 Participants	3 Participants	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	4 Participants	3 Participants	26 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last dose, up to approximately 3 years

Population: Disease response was assessed in the Intent-to-Treat Population.

Complete Response (CR) response criteria included either 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 on the same date as the qualifying BM assessment. CRp response included all CR criteria met, except participant did not experience a platelet recovery (ANC recovery required). CRi response included a qualifying BM result, but not an ANC recovery. Participants may or may not have had a platelet recovery and were not required to be transfusion independent. Partial remission (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. Nonresponders (NR) had a pre- and 1 or more post-baseline BM assessment carried out, but results did not meet any response criteria. Participants who were not evaluable (NE) did not have at least 14 days of treatment and were not assessed.

Outcome measures

Measure	Quizartinib n=3 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID n=8 Participants Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD n=6 Participants Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total n=5 Participants All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID n=5 Participants Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=3 Participants Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=5 Participants Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=6 Participants Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 Participants Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=6 Participants Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=17 Participants Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=8 Participants Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants n=76 Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia composite CR (CR+CRp+CRi)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	5 Participants	1 Participants	10 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Overall response	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	6 Participants	2 Participants	23 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia CR with incomplete platelet recovery	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia CR with incomplete hematologic recovery	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	5 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Partial remission (PR)	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	13 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nonresponder (NR)	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	2 Participants	5 Participants	2 Participants	19 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Not evaluable (NE)	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last dose, up to approximately 3 years

Population: Disease response was assessed in the Evaluable Population.

Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.

Outcome measures

Measure	Quizartinib n=3 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID n=5 Participants Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD n=4 Participants Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total n=4 Participants All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID n=5 Participants Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=2 Participants Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=4 Participants Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=5 Participants Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 Participants Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=4 Participants Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=12 Participants Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=7 Participants Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants n=59 Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	3 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last dose, up to approximately 3 years

Population: Disease response was assessed in the Evaluable Population.

Complete Response (CR) response criteria included either a post-baseline bone marrow biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L on the same date as the qualifying bone marrow assessment. CRp response included all CR criteria met except participant did not experience a platelet recovery. Participants must have experienced an ANC Recovery. CRi response included a qualifying bone marrow result, but did not experience an ANC recovery. Participants may or may not have experienced a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the bone marrow aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline bone marrow assessment carried out, but results did not meet any of the CR or PR or progressive disease criteria.

Outcome measures

Measure	Quizartinib n=3 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID n=5 Participants Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD n=4 Participants Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total n=4 Participants All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID n=5 Participants Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=2 Participants Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=4 Participants Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=5 Participants Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 Participants Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=4 Participants Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=12 Participants Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=7 Participants Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants n=59 Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Overall response	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	1 Participants	6 Participants	2 Participants	22 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Composite CR (CR+CRp+CRi)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	5 Participants	1 Participants	10 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia CR with incomplete platelet recovery	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia CR with incomplete hematologic recovery	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	5 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Partial remission	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	12 Participants
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Nonresponder	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants	2 Participants	5 Participants	2 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last dose, up to approximately 3 years

Population: Hematologic improvement was assessed in the Intent-to-Treat Population.

Hematologic improvement is summarized in terms of Erythroid Response (HI-E), Platelet Response (HI-P), Neutrophil Response (HI-N), and Hematologic Improvement (HI).

For post-treatment results, HI-E major responders had >2 g/dL increase in hemoglobin for at least 1 result after first treatment and transfusion independent; minor responders 1 to 2 g/dL increase in hemoglobin for at least 1 result post first treatment and a 50% decrease in red blood cell transfusion requirements. For HI-P, major responders had ≥30 × 10^9/L increase in platelet count and transfusion independent; minor responders had 50% or more increase in platelet count with a net increase between 10 to 30 × 10^9/L and 50% decrease in platelet transfusion requirements. For HI-N, major responders had an increase in absolute neutrophil count (ANC) of 100% or an absolute increase of more than 0.5 × 10^9/L (whichever is greater); minor responders had an increase in ANC of 100% but an absolute increase of <0.5 × 10^9/L.

Outcome measures

Measure	Quizartinib n=76 Participants Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day. Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule.	Quizartinib 200-450 mg ID Participants received quizartinib (AC220) with doses ranging from 200-450 mg on an intermittent dosing (ID) schedule.	Quizartinib 200-300 mg CD Participants received quizartinib (AC220) with doses ranging from 200-300 mg on a continuous dosing (CD) schedule.	Total All participants who received quizartinib, regardless of dosage or dosing schedule.	Quizartinib 60 mg ID Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.	All Participants All participants who received quizartinib, regardless of dosage and dosing schedule.
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Erythroid Response (HI-E) Responders	35 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Erythroid Response (HI-E) Major Responders	15 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Erythroid Response (HI-E) Minor Responders	20 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Erythroid Response (HI-E) No Response	34 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia HI-E Participants excluded	7 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Platelet Response (HI-P) Responders	39 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Platelet Response (HI-P) Major Responders	18 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Platelet Response (HI-P) Minor Responders	21 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Platelet Response (HI-P) No Response	29 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia HI-P Participants excluded	8 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Neutrophil Response (HI-N) Responders	26 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Neutrophil Response (HI-N) Major Responders	19 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Neutrophil Response (HI-N) Minor Responders	7 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Neutrophil Response (HI-N) No Response	24 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia HI-N Participants excluded	26 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hematologic Improvement (HI) Responders	60 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hematologic Improvement (HI) Any Major Response	38 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Hematologic Improvement (HI) Any Minor Response	22 Participants	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia HI Participants excluded	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Quizartinib 12 mg ID

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Quizartinib 18 mg ID

Serious events: 4 serious events

Other events: 8 other events

Deaths: 8 deaths

Quizartinib 27 mg ID

Serious events: 1 serious events

Other events: 5 other events

Deaths: 6 deaths

Quizartinib 40 mg ID

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

Quizartinib 60 mg ID

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Quizartinib 90 mg ID

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Quizartinib 135 mg ID

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Quizartinib 200 mg ID

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Quizartinib 300 mg ID

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Quizartinib 450 mg ID

Serious events: 5 serious events

Other events: 6 other events

Deaths: 6 deaths

Quizartinib 200 mg CD

Serious events: 9 serious events

Other events: 15 other events

Deaths: 16 deaths

Quizartinib 300 mg CD

Serious events: 8 serious events

Other events: 8 other events

Deaths: 8 deaths

Serious adverse events

Measure	Quizartinib 12 mg ID n=3 participants at risk Participants received quizartinib (AC220) 12 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 18 mg ID n=8 participants at risk Participants received quizartinib (AC220) 18 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 27 mg ID n=6 participants at risk Participants received quizartinib (AC220) 27 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 40 mg ID n=5 participants at risk Participants received quizartinib (AC220) 40 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 60 mg ID n=5 participants at risk Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=3 participants at risk Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=5 participants at risk Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=6 participants at risk Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 participants at risk Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=6 participants at risk Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=17 participants at risk Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=8 participants at risk Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.
Investigations Haemoglobin decreased	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Renal and urinary disorders Renal failure acute	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Disease progression	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	80.0% 4/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	29.4% 5/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Fatigue	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Pyrexia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Pneumonia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Neutropenic sepsis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Abscess neck	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Bronchitis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Creutzfeldt-Jakob disease	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Diverticulitis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Gastrointestinal fungal infection	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Lung infection	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Neutropenic infection	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Sinusitis fungal	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Melaena	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Colitis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Gastrointestinal haemorrrhage	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Ileus	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Cardiac disorders Cardiac failure	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Renal and urinary disorders Calculus urinary	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Renal and urinary disorders Haematuria	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Nervous system disorders Somnolence	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Psychiatric disorders Mental status changes	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Injury, poisoning and procedural complications Subdural haemtoma	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Vascular disorders Haemorrhage	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.

Other adverse events

Measure	Quizartinib 12 mg ID n=3 participants at risk Participants received quizartinib (AC220) 12 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 18 mg ID n=8 participants at risk Participants received quizartinib (AC220) 18 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 27 mg ID n=6 participants at risk Participants received quizartinib (AC220) 27 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 40 mg ID n=5 participants at risk Participants received quizartinib (AC220) 40 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 60 mg ID n=5 participants at risk Participants received quizartinib (AC220) 60 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 90 mg ID n=3 participants at risk Participants received quizartinib (AC220) 90 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 135 mg ID n=5 participants at risk Participants received quizartinib (AC220) 135 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg ID n=6 participants at risk Participants received quizartinib (AC220) 200 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 300 mg ID n=4 participants at risk Participants received quizartinib (AC220) 300 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 450 mg ID n=6 participants at risk Participants received quizartinib (AC220) 450 mg/day on an intermittent dosing (ID) schedule.	Quizartinib 200 mg CD n=17 participants at risk Participants received quizartinib (AC220) 200 mg/day on a continuous dosing (CD) schedule.	Quizartinib 300 mg CD n=8 participants at risk Participants received quizartinib (AC220) 300 mg/day on a continuous dosing (CD) schedule.
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	60.0% 3/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	83.3% 5/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	35.3% 6/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Pyrexia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	60.0% 3/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 2/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	41.2% 7/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Fatigue	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	60.0% 3/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 2/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	35.3% 6/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Disease progression	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	80.0% 4/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	29.4% 5/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	60.0% 3/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 2/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	29.4% 5/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Odema peripheral	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 2/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	17.6% 3/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	41.2% 7/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	100.0% 3/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	60.0% 3/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Skin and subcutaneous tissue disorders Petechiae	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	17.6% 3/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	35.3% 6/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Nervous system disorders Headache	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 2/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Vascular disorders Hypotension	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Infections and infestations Pneumonia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	17.6% 3/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Asthenia	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	66.7% 4/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Psychiatric disorders Confusional state	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	37.5% 3/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Nervous system disorders Dysgeusia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 2/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	40.0% 2/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 2/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	5.9% 1/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Investigations ECG QT prolonged	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	23.5% 4/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 4/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Cardiac disorders Tachycardia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
General disorders Chills	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	50.0% 3/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	25.0% 1/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	11.8% 2/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	16.7% 1/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	29.4% 5/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/3 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	20.0% 1/5 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/4 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	0.00% 0/6 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	29.4% 5/17 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.	12.5% 1/8 • Adverse events were collected from after initiation of study drug up to 30 days after last dose, up to approximately 3 years.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

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