Trial Outcomes & Findings for Lerapolturev in Recurrent Malignant Glioma (NCT NCT02986178)

NCT ID: NCT02986178

Last Updated: 2025-07-11

Results Overview

Assess objective anti-tumor response based on iRANO criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 121 participants
• Primary outcome timeframe: up to 5 years
• Results posted on: 2025-07-11

Participant Flow

The lerapolturev + lomustine arm was closed after interim review. Recruitment to the lerapolturev alone arm remained open.

Safety set includes all enrolled participants who had an infusion catheter placed. Full-analysis set includes all randomized participants who received lerapolturev treatment.

Participant milestones

Measure	Lerapolturev lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing	Not Treated Includes a participant who had an infusion catheter placed but withdrew from the study prior to receiving lerapolturev.
Overall Study STARTED	93	27	1
Overall Study COMPLETED	93	27	0
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lerapolturev in Recurrent Malignant Glioma

Baseline characteristics by cohort

Measure	Lerapolturev n=93 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=27 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing	Total n=120 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 12.4 • n=5 Participants	50 years STANDARD_DEVIATION 13.6 • n=7 Participants	54 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	11 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	16 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	27 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	26 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	27 participants n=7 Participants	120 participants n=5 Participants
Karnofsky Performance Status 70	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Karnofsky Performance Status 80	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Karnofsky Performance Status 90	60 Participants n=5 Participants	17 Participants n=7 Participants	77 Participants n=5 Participants
Karnofsky Performance Status 100	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Assess objective anti-tumor response based on iRANO criteria.

Outcome measures

Measure	Lerapolturev n=93 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=27 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Number of Participants With Objective Radiographic Response	5 Participants	2 Participants

PRIMARY outcome

Timeframe: up to 5 years

Assess time of confirmed response to confirmed disease progression or death

Outcome measures

Measure	Lerapolturev n=5 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=2 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Duration of Objective Radiographic Response	NA months NA = None of the participants with a confirmed response had documented disease progression or death; therefore, the DOR estimates were deemed not estimable (NE). The value "NA" has been entered as the system requires a numerical entry (ie, NE for not estimable cannot be entered).	NA months NA = None of the participants with a confirmed response had documented disease progression or death; therefore, the DOR estimates were deemed not estimable (NE). The value "NA" has been entered as the system requires a numerical entry (ie, NE for not estimable cannot be entered).

SECONDARY outcome

Timeframe: up to 5 years

Overall Survival (months), calculated using the Kaplan-Meier method

Outcome measures

Measure	Lerapolturev n=93 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=27 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Median Overall Survival	7.0 months Interval 5.8 to 9.1	7.1 months Interval 4.0 to 8.1

SECONDARY outcome

Timeframe: at 24 and 36 months post-lerapolturev infusion

Overall survival (months) at 24 and 36 months, calculated using the Kaplan-Meier method

Outcome measures

Measure	Lerapolturev n=93 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=27 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Landmark Survival Probability of being alive at 24 months	0.12 proportion probability Interval 0.06 to 0.21	0.19 proportion probability Interval 0.07 to 0.35
Landmark Survival Probability of being alive at 36 months	0.07 proportion probability Interval 0.02 to 0.15	0.11 proportion probability Interval 0.03 to 0.26

SECONDARY outcome

Timeframe: up to 5 years

the percentage of participants achieving complete response, partial response, or stable disease

Outcome measures

Measure	Lerapolturev n=93 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=27 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Disease Control Rate	51 percentage of participants Interval 40.0 to 61.0	48 percentage of participants Interval 29.0 to 68.0

SECONDARY outcome

Timeframe: up to 52 weeks

Population: The safety set includes all participants who had an infusion catheter placed.

Number of participants experiencing Grade 3, 4 or 5 adverse events considered possibly, probably, or definitely related to protocol treatment

Outcome measures

Measure	Lerapolturev n=94 Participants lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=26 Participants lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Safety of Lerapolturev	17 Participants	8 Participants

Adverse Events

Lerapolturev

Serious events: 37 serious events

Other events: 94 other events

Deaths: 8 deaths

Lerapolturev + Lomustine

Serious events: 12 serious events

Other events: 26 other events

Deaths: 4 deaths

Overall

Serious events: 50 serious events

Other events: 121 other events

Deaths: 12 deaths

Serious adverse events

Measure	Lerapolturev n=94 participants at risk lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=26 participants at risk lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing	Overall n=121 participants at risk includes a participant who had an infusion catheter placed and did not receive lerapolturev
Nervous system disorders hemiparesis	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	23.1% 6/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.6% 14/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders seizure	9.6% 9/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.6% 14/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders aphasia	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders haemorrhage intracranial	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders brain oedema	2.1% 2/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.3% 4/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders hydrocephalus	2.1% 2/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders ataxia	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders encephalopathy	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders somnolence	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations sepsis	4.3% 4/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	4.1% 5/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations urinary tract infection	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	4.1% 5/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations abdominal abscess	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations anorectal infection	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations Ludwig angina	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations respiratory tract infection	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations skin infection	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Vascular disorders embolism	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Vascular disorders haematoma	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders confusional state	4.3% 4/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders depression	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders fatigue	3.2% 3/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	2.5% 3/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders cyst	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders localised edema	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders pain	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders pyrexia	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) peritumoral oedema	2.1% 2/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) gastrointestinal stromal tumour	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) hepatic cancer metastatic	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasm progression	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders gastric haemorrhage	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders gastric ulcer	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders haemorrhoidal haemorrhage	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders large intestine perforation	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders lower gastrointestinal haemorrhage	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Cardiac disorders cardiac arrest	3.2% 3/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	2.5% 3/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Injury, poisoning and procedural complications fall	2.1% 2/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Injury, poisoning and procedural complications rib fracture	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypoalbuminaemia	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hyponatraemia	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Musculoskeletal and connective tissue disorders muscular weakness	2.1% 2/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.00% 0/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Renal and urinary disorders urinary incontinence	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders aspiration	1.1% 1/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	1.7% 2/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations platelet count decreased	0.00% 0/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	0.83% 1/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders headache	3.2% 3/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.

Other adverse events

Measure	Lerapolturev n=94 participants at risk lerapolturev administered once intratumorally by convection-enhanced delivery	Lerapolturev + Lomustine n=26 participants at risk lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing	Overall n=121 participants at risk includes a participant who had an infusion catheter placed and did not receive lerapolturev
Nervous system disorders headache	67.0% 63/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	84.6% 22/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	70.2% 85/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders hemiparesis	67.0% 63/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	84.6% 22/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	70.2% 85/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders seizure	42.6% 40/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	65.4% 17/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	47.1% 57/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders aphasia	37.2% 35/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	34.6% 9/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	36.4% 44/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders memory impairment	23.4% 22/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	21.5% 26/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders cognitive disorder	16.0% 15/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	14.9% 18/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders paraesthesia	11.7% 11/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	13.2% 16/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders dizziness	9.6% 9/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	23.1% 6/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	12.4% 15/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders tremor	9.6% 9/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders hemianopia	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders haemorrhage intracranial	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders somnolence	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Nervous system disorders facial paresis	4.3% 4/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations lymphocyte count decreased	44.7% 42/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	84.6% 22/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	52.9% 64/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations platelet count decreased	34.0% 32/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	100.0% 26/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	47.9% 58/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations white blood cell count decreased	23.4% 22/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	69.2% 18/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	33.1% 40/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations alanine aminotransferase increased	22.3% 21/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	50.0% 13/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	28.1% 34/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations aspartate aminotransferase increased	19.1% 18/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	30.8% 8/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	21.5% 26/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations neutrophil count decreased	11.7% 11/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	42.3% 11/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	18.2% 22/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations blood creatinine increased	14.9% 14/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	13.2% 16/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations blood bilirubin increased	10.6% 10/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.9% 12/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Investigations blood alkaline phosphatase increased	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hyperglycemia	46.8% 44/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	76.9% 20/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	52.9% 64/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypocalcaemia	38.3% 36/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	53.8% 14/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	41.3% 50/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypoalbuminaemia	31.9% 30/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	57.7% 15/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	37.2% 45/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypokalaemia	28.7% 27/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	53.8% 14/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	33.9% 41/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hyponatraemia	24.5% 23/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	46.2% 12/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	28.9% 35/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders decreased appetite	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	10.7% 13/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hyperkalaemia	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypernatraemia	9.6% 9/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Metabolism and nutrition disorders hypoglycaemia	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders fatigue	56.4% 53/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	53.8% 14/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	55.4% 67/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders pain	27.7% 26/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	26.9% 7/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	27.3% 33/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders gait disturbance	11.7% 11/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	10.7% 13/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders oedema peripheral	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.9% 12/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
General disorders influenza like illness	3.2% 3/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Blood and lymphatic system disorders anaemia	51.1% 48/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	76.9% 20/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	56.2% 68/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders nausea	20.2% 19/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	30.8% 8/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	22.3% 27/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders diarrhoea	10.6% 10/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	34.6% 9/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.7% 19/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders constipation	14.9% 14/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	14.0% 17/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders stomatitis	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	23.1% 6/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.1% 11/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders vomiting	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders gastrooesophageal reflux disease	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Gastrointestinal disorders anal incontinence	3.2% 3/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders confusional state	24.5% 23/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	23.1% 28/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders insomnia	19.1% 18/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	30.8% 8/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	21.5% 26/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders agitation	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.1% 11/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders depression	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Psychiatric disorders anxiety	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Vascular disorders hypertension	47.9% 45/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	50.0% 13/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	47.9% 58/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Vascular disorders embolism	9.6% 9/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	10.7% 13/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders cough	10.6% 10/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.1% 11/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders epistaxis	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.1% 11/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders dyspnoea	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders dysphonia	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders rhinitis allergic	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders nasal congestion	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	6.4% 6/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations urinary tract infection	11.7% 11/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	10.7% 13/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Infections and infestations upper respiratory tract infection	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.9% 12/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Musculoskeletal and connective tissue disorders muscular weakness	13.8% 13/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	14.9% 18/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Musculoskeletal and connective tissue disorders arthralgia	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Musculoskeletal and connective tissue disorders back pain	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.0% 6/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Renal and urinary disorders urinary incontinence	4.3% 4/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	30.8% 8/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.9% 12/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Renal and urinary disorders proteinuria	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	8.3% 10/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Renal and urinary disorders haematuria	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	15.4% 4/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.4% 9/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Renal and urinary disorders pollakiuria	7.4% 7/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Skin and subcutaneous tissue disorders rash maculo-papular	5.3% 5/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	6.6% 8/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Skin and subcutaneous tissue disorders rash	4.3% 4/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	11.5% 3/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	5.8% 7/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Injury, poisoning and procedural complications fall	16.0% 15/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	3.8% 1/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	13.2% 16/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Eye disorders vision blurred	10.6% 10/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	7.7% 2/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	9.9% 12/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.
Cardiac disorders sinus tachycardia	8.5% 8/94 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	19.2% 5/26 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.	10.7% 13/121 • Adverse events were collected until study discontinuation, up to 5 years. The safety set includes all enrolled participants who had an infusion catheter placed. Participants are displayed based on actual treatment received.

Additional Information

Head of Clinical Operations

Istari Oncology

Phone: 919-245-7662

Email: info@istarioncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo. The sponsor can require changes to the communication with respect to confidential information that is not necessary for the complete and accurate presentation and interpretation of the study results.
• Publication restrictions are in place

Restriction type: OTHER