Trial Outcomes & Findings for Photopheresis for the Treatment of Acute Graft Versus Host Disease (NCT NCT00609609)

Last Updated: 2018-06-04

Results Overview

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on \>1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on \> 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

Results posted on

2018-06-04

Participant Flow

Recruitment Period: January 23, 2008 to November 19, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Corticosteroids Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Overall Study STARTED	30	51
Overall Study COMPLETED	24	49
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Corticosteroids Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Overall Study Withdrawal by Subject	2	0
Overall Study Progression	4	2

Baseline Characteristics

Photopheresis for the Treatment of Acute Graft Versus Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Corticosteroids n=30 Participants Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 Participants Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	Total n=81 Participants Total of all reporting groups
Sex: Female, Male Male	19 Participants n=93 Participants	31 Participants n=4 Participants	50 Participants n=27 Participants
Region of Enrollment United States	30 participants n=93 Participants	51 participants n=4 Participants	81 participants n=27 Participants
Ablative Conditioned	23 Participants n=93 Participants	33 Participants n=4 Participants	56 Participants n=27 Participants
Age, Continuous	53 years n=93 Participants	54 years n=4 Participants	54 years n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	20 Participants n=4 Participants	31 Participants n=27 Participants
GVHD Prophylaxis Tacrolimus/MTX	28 Participants n=93 Participants	44 Participants n=4 Participants	72 Participants n=27 Participants
GVHD Prophylaxis Tacrolimus/Mycophenolate	0 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants
GVHD Prophylaxis Other	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Donor Relation Related	12 Participants n=93 Participants	18 Participants n=4 Participants	30 Participants n=27 Participants
Donor Relation Unrelated	18 Participants n=93 Participants	33 Participants n=4 Participants	51 Participants n=27 Participants
Donor Match Matched	24 Participants n=93 Participants	41 Participants n=4 Participants	65 Participants n=27 Participants
Donor Match Mismatched/Haploidentical	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Graft Source Peripheral Blood	25 Participants n=93 Participants	36 Participants n=4 Participants	61 Participants n=27 Participants
Graft Source Bone Marrow	5 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants
Graft Source Umbilical Cord	0 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

Outcome measures

Outcome measures
Measure	Corticosteroids n=30 Participants Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 Participants Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Day 56 Treatment Success Skin-only	57 percentage of participants	72 percentage of participants
Day 56 Treatment Success Visceral Involvement	43 percentage of participants	47 percentage of participants
Day 56 Treatment Success Total	53 percentage of participants	65 percentage of participants

POST_HOC outcome

Timeframe: Up to day 56

Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56.

Outcome measures

Outcome measures
Measure	Corticosteroids n=30 Participants Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 Participants Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56 Day 28 Steroid dose </= 0.25mg/kg	10 percentage of participants	23.5 percentage of participants
Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56 Day 56 steroid dose < 0.1mg/kg	30 percentage of participants	43 percentage of participants

POST_HOC outcome

Timeframe: 6 months

Percentage of participants at 6 months whose deaths were without relapse/recurrence.

Outcome measures

Outcome measures
Measure	Corticosteroids n=30 Participants Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 Participants Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Non-relapse Mortality (NRM) at 6 Months	19.6 percentage of participants Interval 8.6 to 30.6	20.0 percentage of participants Interval 5.4 to 34.6

Adverse Events

Corticosteroids

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

ECP + Corticosteroids

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Corticosteroids n=30 participants at risk Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 participants at risk Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
General disorders Graft versus Host Disease (GVHD)	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Refractory GVHD	6.7% 2/30 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Pneumonia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Hepatobiliary disorders Liver Failure	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
General disorders Multi-system organ failure	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders GI GVHD	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.

Other adverse events

Additional Information

Dr. Amin Majid Alousi, Associate Professor, Stem Cell Transplantation

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Corticosteroids n=30 participants at risk Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.	ECP + Corticosteroids n=51 participants at risk Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Injury, poisoning and procedural complications acute kidney injury	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders acute renal failure	6.7% 2/30 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Adenovirus infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Psychiatric disorders Altered mental status	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Psychiatric disorders anxiety	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders aspergillus pneumonia infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders bilateral pneumonia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations BK virus infection	13.3% 4/30 • Number of events 4 • Adverse events collected through weekly treatments for up to 60 days.	11.8% 6/51 • Number of events 6 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders bladder spasms	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations candida albicansfungus infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders candida glabrata pneumonia	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Surgical and medical procedures catheter related mycobateremia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Cytomegalovirus (CMV) infection	16.7% 5/30 • Number of events 5 • Adverse events collected through weekly treatments for up to 60 days.	21.6% 11/51 • Number of events 11 • Adverse events collected through weekly treatments for up to 60 days.
Nervous system disorders Central Nervous System (CNS) ischemia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders cystitis	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	5.9% 3/51 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.
Skin and subcutaneous tissue disorders Decubitus ulcer	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Surgical and medical procedures delayed infusion reactions	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders diarrhea	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	5.9% 3/51 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders diverticulitis	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders dyspnea	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders dysuria	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations e. coli urinary tract infection (UTI)	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
General disorders edema	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Investigations Alanine aminotransferase increased (elevated ALT)	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	7.8% 4/51 • Number of events 4 • Adverse events collected through weekly treatments for up to 60 days.
Investigations Aspartate transaminase increased (AST)	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Investigations elevated bilirubin	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Investigations elevated creatinine	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations enterococcus infection	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
General disorders flu-like symptoms	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders GI bleed	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders GI Graft versus Host Disease (GVHD)	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations gram positive cocci infection	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders ground glass opacity bilateral lungs	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders hematuria	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
General disorders hemorrage	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations herpes infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations HHV6 infection	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Metabolism and nutrition disorders hyperglycemia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Metabolism and nutrition disorders hypomagnesemia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Investigations increase creatinine	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations infection	6.7% 2/30 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations influenza infection	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Hepatobiliary disorders Liver Graft versus Host Disease (GVHD)	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Musculoskeletal and connective tissue disorders muscle weakness	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Musculoskeletal and connective tissue disorders myositis	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders nausea	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations norovirus infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Eye disorders ocular gvhd	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders parafluenza pneumonia	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	5.9% 3/51 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Parvovirus	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Cardiac disorders Pericardial effusion	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders peritoneal fluid infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders pneumonitis	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations polymicrobial infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations pseudomonas aeruginosa bacteremia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	5.9% 3/51 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.
Skin and subcutaneous tissue disorders rash	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders Renal dysfunction	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders Respiratory effusion	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders RSV pneumonia	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations sepsis	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Skin and subcutaneous tissue disorders skin rash	10.0% 3/30 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.	17.6% 9/51 • Number of events 9 • Adverse events collected through weekly treatments for up to 60 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations staphylococcus infection	6.7% 2/30 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.	7.8% 4/51 • Number of events 4 • Adverse events collected through weekly treatments for up to 60 days.
Respiratory, thoracic and mediastinal disorders staphylococcus lower respiratory infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Gastrointestinal disorders stomatitis	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Vascular disorders thrombosis	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	7.8% 4/51 • Number of events 4 • Adverse events collected through weekly treatments for up to 60 days.
Vascular disorders Thrombotic microangiopathy	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.
Musculoskeletal and connective tissue disorders toe pain	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders urinary tract infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Renal and urinary disorders urine staphylococcus infection	6.7% 2/30 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.	5.9% 3/51 • Number of events 3 • Adverse events collected through weekly treatments for up to 60 days.
Infections and infestations Vancomycin resistent enterococci infection	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	3.9% 2/51 • Number of events 2 • Adverse events collected through weekly treatments for up to 60 days.
Vascular disorders Vascular obstruction	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Hepatobiliary disorders Hepatic veno-occlusive disease	0.00% 0/30 • Adverse events collected through weekly treatments for up to 60 days.	2.0% 1/51 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.
Nervous system disorders viral encephalopathy	3.3% 1/30 • Number of events 1 • Adverse events collected through weekly treatments for up to 60 days.	0.00% 0/51 • Adverse events collected through weekly treatments for up to 60 days.