Trial Outcomes & Findings for TAC T-cells for the Treatment of HER2-positive Solid Tumors (NCT NCT04727151)

NCT ID: NCT04727151

Last Updated: 2025-06-08

Results Overview

A DLT is defined as: * Grade 4 or 5 events determined by the Investigator to be related to the investigational product, with the exception of Grade 4 laboratory abnormalities that are rapidly reversible or correctable without substantial safety concerns. * Grade ≥3 TAC T cell-associated acute infusion reactions persisting for ≥24 hours * Grade ≥3 TAC T cell-associated CRS or neurotoxicity persisting for ≥72 hours * Grade ≥3 cardiovascular or pulmonary toxicity persisting for ≥72 hours * Grade ≥3 immune-related toxicities * Grade ≥3 organ toxicities or non-hematologic toxicities that do not improve to baseline within 7 days * Clinically consequential Grade ≥3 neutropenia or thrombocytopenia lasting ≥30 days from TAC01-HER2 administration. Clinically consequential is defined as febrile neutropenia, serious infection, or bleeding events.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2025-06-08

Participant Flow

In addition to the 23 subjects who were assigned to groups, 5 additional subjects were enrolled but not not assigned to groups: * 3 died before group assignment * 2 failed to meet pre-treatment inclusion criteria

Participant milestones

Measure	TAC01-HER2 DL1 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	Unassigned Not Treated
Overall Study STARTED	4	4	3	12	5
Overall Study COMPLETED	4	4	3	12	0
Overall Study NOT COMPLETED	0	0	0	0	5

Reasons for withdrawal

Measure	TAC01-HER2 DL1 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	Unassigned Not Treated
Overall Study Death	0	0	0	0	3
Overall Study failed to meet pre-treatment inclusion criteria	0	0	0	0	2

Baseline Characteristics

TAC T-cells for the Treatment of HER2-positive Solid Tumors

Baseline characteristics by cohort

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=12 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	Total n=23 Participants Total of all reporting groups
Age, Continuous	65.5 years n=5 Participants	61.5 years n=7 Participants	52 years n=5 Participants	59 years n=4 Participants	59 years n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 0	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 1	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants
Cancer type Breast	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Cancer type Gastric	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Cancer type Other	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Stage of disease at screening Stage III	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Stage of disease at screening Stage IV	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	19 Participants n=21 Participants
Stage of disease at screening Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Bridging therapy Yes	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants
Bridging therapy No	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days

Population: One participant at DL4 was classified as non-evaluable due to a fatal aspiration pneumonia event (unrelated to TAC01-HER2) before the DLT period elapsed.

A DLT is defined as:

• Grade 4 or 5 events determined by the Investigator to be related to the investigational product, with the exception of Grade 4 laboratory abnormalities that are rapidly reversible or correctable without substantial safety concerns.
• Grade ≥3 TAC T cell-associated acute infusion reactions persisting for ≥24 hours
• Grade ≥3 TAC T cell-associated CRS or neurotoxicity persisting for ≥72 hours
• Grade ≥3 cardiovascular or pulmonary toxicity persisting for ≥72 hours
• Grade ≥3 immune-related toxicities
• Grade ≥3 organ toxicities or non-hematologic toxicities that do not improve to baseline within 7 days
• Clinically consequential Grade ≥3 neutropenia or thrombocytopenia lasting ≥30 days from TAC01-HER2 administration. Clinically consequential is defined as febrile neutropenia, serious infection, or bleeding events.

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Incidence of Dose Limiting Toxicities (DLTs) Yes	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1: Incidence of Dose Limiting Toxicities (DLTs) No	4 Participants	4 Participants	3 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 28 Days Post TAC01-HER2 infusion

Population: One subjects was classified as non-evaluable due to a fatal aspiration pneumonia event (unrelated to TAC01-HER2) before the period lapsed

RP2D was determined by the Data and Safety Monitoring Committee using the keyboard design method (<95% chance that the DLT rate exceeds 30%).

Outcome measures

Measure	TAC01-HER2 DL1 n=22 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Determine Recommended Phase 2 Dose (RP2D) for TAC01-HER2 Monotherapy	7000000 TAC01-HER2 cells/kg	—	—	—

SECONDARY outcome

Timeframe: 24 months

Population: One subject at DL4 was classified as non-evaluable due to a fatal aspiration pneumonia event (unrelated to TAC01-HER2) before the first scheduled follow-up assessment.

Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Evaluate Overall Response Rate (ORR)	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 months

Population: One subject at DL4 was classified as non-evaluable due to a fatal aspiration pneumonia event (unrelated to TAC01-HER2) before the first scheduled follow-up assessment.

Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Evaluate Duration of Response (DoR)	0 months Interval 0.0 to 0.0	2.2 months Interval 2.2 to 2.2	0 months Interval 0.0 to 0.0	1.9 months Interval 1.9 to 1.9

SECONDARY outcome

Timeframe: 6 months

Defined as participants alive after 6 months

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=12 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Evaluate Overall Survival (OS)	2 Participants	4 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 months

Population: One subject at DL4 was classified as non-evaluable due to a fatal aspiration pneumonia event (unrelated to TAC01-HER2) before the first scheduled follow-up assessment.

Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Evaluate Disease Control Rate (DCR)	0 Participants	3 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 24 months

Population: One participant at DL2 withdrew consent before disease progression and was thus unevaluable for PFS.

Defined as time from infusion to disease progression or death from any cause

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=12 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Progression-Free Survival (PFS) or Time to Progression (TTP)	0.9 months Interval 0.8 to 1.0	2.8 months Interval 0.9 to 12.4	2.6 months Interval 1.0 to 4.7	0.95 months Interval 0.1 to 3.2

SECONDARY outcome

Timeframe: Pre-treatment, days 3, 4 or 5, 8, 11, 14 or15, 18, 21 or 22, 25, 29, 42, months 3, 6, 9, 12, 18, 24 or end of study, and at the confirmatory progressive disease visit

Population: One subject at DL4 was non-evaluable.

Defined as the maximum concentration of TAC T cells after infusion; assessed by vector copy number

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1: Cmax of TAC01-HER2 (Pharmacokinetics; PK)	75.5 vector copy number/μg gDNA Interval 39.0 to 853.0	247 vector copy number/μg gDNA Interval 29.0 to 1640.0	63 vector copy number/μg gDNA Interval 52.0 to 206.0	797 vector copy number/μg gDNA Interval 202.0 to 5288.0

SECONDARY outcome

Timeframe: Pre-treatment, days 3, 4 or 5, 8, 11, 14 or15, 18, 21 or 22, 25, 29, 42, months 3, 6, 9, 12, 18, 24 or end of study, and at the confirmatory progressive disease visit

Population: One subject at DL4 was non-evaluable.

Defined as the the first study day the Cmax is reached

Outcome measures

Measure	TAC01-HER2 DL1 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=11 Participants Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide
Phase 1 and Phase 2: Tmax of TAC01-HER2 (PK)	4 days after infusion Interval 4.0 to 29.0	18.5 days after infusion Interval 11.0 to 22.0	15 days after infusion Interval 15.0 to 22.0	8 days after infusion Interval 8.0 to 22.0

Adverse Events

TAC01-HER2 DL1

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

TAC01-HER2 DL2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

TAC01-HER2 DL3

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

TAC01-HER2 DL4

Serious events: 9 serious events

Other events: 12 other events

Deaths: 5 deaths

Unassigned

Serious events: 3 serious events

Other events: 3 other events

Deaths: 4 deaths

Serious adverse events

Measure	TAC01-HER2 DL1 n=4 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=12 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	Unassigned n=5 participants at risk Not Treated
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Constipation	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Obstruction gastric	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Disease progression	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	60.0% 3/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Immune system disorders Cytokine release syndrome	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Haematuria	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Hydronephrosis	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Vascular disorders Hypotension	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Infections and infestations Bacteremia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Partial Duodenal Obstruction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Cardiac disorders Thromboembolic Event	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Transaminitis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).

Other adverse events

Measure	TAC01-HER2 DL1 n=4 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL2 n=4 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^5 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL3 n=3 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 1-3x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	TAC01-HER2 DL4 n=12 participants at risk Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration. TAC01-HER2: 6-8x10\^6 TAC01-HER2 and: * fludarabine and cyclophosphamide, or * cyclophosphamide	Unassigned n=5 participants at risk Not Treated
Blood and lymphatic system disorders Leukopenia	100.0% 4/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	100.0% 4/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	66.7% 8/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Neutropenia	75.0% 3/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	100.0% 4/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	66.7% 8/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Anaemia	75.0% 3/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	75.0% 3/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	41.7% 5/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Lymphopenia	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	41.7% 5/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	75.0% 3/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Fatigue	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Pyrexia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Disease progression	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	60.0% 3/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Oedema	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	66.7% 2/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Catheter site erythema	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Chest pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Gait disturbance	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Influenza like illness	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Non-cardiac chest pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Oedema peripheral	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
General disorders Procedural pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Nausea	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	66.7% 2/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	58.3% 7/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Vomiting	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Constipation	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Dysphagia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Obstruction gastric	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypocalcaemia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Acidosis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Alkalosis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Fluid overload	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hyperuricaemia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hypokalaemia	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Metabolism and nutrition disorders Refeeding syndrome	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Immune system disorders Cytokine release syndrome	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	100.0% 3/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	91.7% 11/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Immune system disorders Hypersensitivity	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Alanine aminotransferase increased	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Weight decreased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Serum ferritin increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood bilirubin increased	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood fibrinogen increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations C-reactive protein increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Electrocardiogram QT prolonged	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood bicarbonate decreased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood creatinine increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Blood uric acid decreased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Coronavirus test positive	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations Fibrin D dimer increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Investigations International normalised ratio increased	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 4/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Vascular disorders Hypotension	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	75.0% 3/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Vascular disorders Hypertension	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Cardiac disorders Tachycardia	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Cardiac disorders Ventricular tachycardia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Headache	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	41.7% 5/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Dizziness	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Dysgeusia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Dysarthria	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Encephalopathy	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Nervous system disorders Sciatica	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	50.0% 2/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	16.7% 2/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Psychiatric disorders Insomnia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 3/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Psychiatric disorders Depression	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Chromaturia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Haematuria	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Hydronephrosis	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Injury, poisoning and procedural complications Gastrostomy tube site complication	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Hepatobiliary disorders Gallbladder oedema	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	33.3% 1/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Infections and infestations Cystitis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	8.3% 1/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Infections and infestations Wound infection	25.0% 1/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Infections and infestations Bacteremia	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Infections and infestations Fever	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Gastrointestinal disorders Partial Duodenal Obstruction	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Cardiac disorders Thromboembolic Event	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).
Blood and lymphatic system disorders Transaminitis	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/4 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/3 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	0.00% 0/12 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).	20.0% 1/5 • Adverse Events were collected for a period of 90 days. All-Cause Mortality was assessed through study completion for each participant (for up to 2 years).

Additional Information

Maria Apostolopoulou, Clinical Scientist

Triumvira Immunologics

Phone: 518-892-8426

Email: mapostolopoulou@triumvira.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs have the right to publish or discuss the results of the Study provided such disclosure is submitted to the SPONSOR for review and comment 45 days prior to submission for publication or 60 days prior to presentation. The PIs have agreed to defer disclosure at the request of the SPONSOR, to permit the filing of any desired patent applications. Any disclosure based on the results obtained at PI's Site shall not be made before the first multi-centre publication.
• Publication restrictions are in place

Restriction type: OTHER