Trial Outcomes & Findings for Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial (NCT NCT02561455)

Last Updated: 2024-11-19

Results Overview

AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)

Results posted on

2024-11-19

Participant Flow

Participants from previosuly conducted ASP2215 trial were recruited to receive gilteritinib at a dose specified at the time of their end of study visit in the previous ASP2215 study.

Participants with Acute myeloid leukemia (AML) and advanced solid tumors who completed the protocol requirements of the previous ASP2215 trial (NCT02014558 and NCT02456883) were included in this study. 9 participants were screened.

Participant milestones

Participant milestones
Measure	Gilteritinib 40 mg Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
Overall Study STARTED	2	3	3	1
Overall Study COMPLETED	0	1	0	0
Overall Study NOT COMPLETED	2	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gilteritinib 40 mg Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
Overall Study Participant Transitioned to Commercial Drug	1	1	2	1
Overall Study Withdrawal by Subject	1	0	1	0
Overall Study Disease Progression	0	1	0	0

Baseline Characteristics

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gilteritinib 40 mg n=2 Participants Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg n=3 Participants Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg n=3 Participants Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg n=1 Participants Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Total n=9 Participants Total of all reporting groups
Age, Continuous	47.5 Years STANDARD_DEVIATION 17.7 • n=5 Participants	41 Years STANDARD_DEVIATION 17.5 • n=7 Participants	55.7 Years STANDARD_DEVIATION 12.1 • n=5 Participants	31.0 Years n=4 Participants	46.2 Years STANDARD_DEVIATION 15.0 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)

Population: Participants in the SAF were analyzed.

Outcome measures

Outcome measures
Measure	Gilteritinib 40 mg n=2 Participants Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg n=3 Participants Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg n=3 Participants Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg n=1 Participants Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
Number of Participants With Adverse Events	2 Participants	3 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)

Population: Participants in the SAF with available data were analyzed.

ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported.

Outcome measures

Outcome measures
Measure	Gilteritinib 40 mg n=2 Participants Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg n=3 Participants Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg n=1 Participants Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg n=1 Participants Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 0	2 Participants	0 Participants	0 Participants	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 1	0 Participants	3 Participants	0 Participants	1 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 2	0 Participants	0 Participants	1 Participants	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Grade 5	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Gilteritinib 40 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Gilteritinib 80 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Gilteritinib 120 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Gilteritinib 200 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gilteritinib 40 mg n=2 participants at risk Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 80 mg n=3 participants at risk Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 120 mg n=3 participants at risk Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.	Gilteritinib 200 mg n=1 participants at risk Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
General disorders Pyrexia	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Infections and infestations Appendicitis	50.0% 1/2 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Infections and infestations Respiratory syncytial virus infection	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Infections and infestations Staphylococcal bacteraemia	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	50.0% 1/2 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Vascular disorders Hypotension	0.00% 0/2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)	0.00% 0/1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)

Other adverse events

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development, Inc

Phone: 800-888-7704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement."
Publication restrictions are in place

Restriction type: OTHER