Trial Outcomes & Findings for IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC (NCT NCT05077709)

NCT ID: NCT05077709

Last Updated: 2026-04-08

Results Overview

Confirmed Objective Response Rate according to RECIST v1.1

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years.

Results posted on

2026-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (NSCLC) NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm C (mUBC) mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Overall Study STARTED	37	21	5
Overall Study COMPLETED	7	2	2
Overall Study NOT COMPLETED	30	19	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (NSCLC) NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm C (mUBC) mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Overall Study Multiple reasons outlines in data	30	19	3

Baseline Characteristics

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (NSCLC) n=37 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=21 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm C (mUBC) n=5 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Total n=63 Participants Total of all reporting groups
Age, Customized Age (years)	71.0 years n=527 Participants	69.0 years n=527 Participants	83.0 years n=1054 Participants	71.0 years n=157 Participants
Sex: Female, Male Female	19 Participants n=527 Participants	7 Participants n=527 Participants	3 Participants n=1054 Participants	29 Participants n=157 Participants
Sex: Female, Male Male	18 Participants n=527 Participants	14 Participants n=527 Participants	2 Participants n=1054 Participants	34 Participants n=157 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Asian	0 Participants n=527 Participants	2 Participants n=527 Participants	0 Participants n=1054 Participants	2 Participants n=157 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Black or African American	1 Participants n=527 Participants	1 Participants n=527 Participants	0 Participants n=1054 Participants	2 Participants n=157 Participants
Race (NIH/OMB) White	36 Participants n=527 Participants	16 Participants n=527 Participants	4 Participants n=1054 Participants	56 Participants n=157 Participants
Race (NIH/OMB) More than one race	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=527 Participants	2 Participants n=527 Participants	1 Participants n=1054 Participants	3 Participants n=157 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=527 Participants	4 Participants n=527 Participants	0 Participants n=1054 Participants	6 Participants n=157 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=527 Participants	14 Participants n=527 Participants	4 Participants n=1054 Participants	50 Participants n=157 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=527 Participants	3 Participants n=527 Participants	1 Participants n=1054 Participants	7 Participants n=157 Participants
Region of Enrollment United States	1 Participants n=527 Participants	12 Participants n=527 Participants	2 Participants n=1054 Participants	15 Participants n=157 Participants
Region of Enrollment United Kingdom	7 Participants n=527 Participants	2 Participants n=527 Participants	0 Participants n=1054 Participants	9 Participants n=157 Participants
Region of Enrollment Spain	29 Participants n=527 Participants	7 Participants n=527 Participants	3 Participants n=1054 Participants	39 Participants n=157 Participants
Metastasis status Liver metastasis	5 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants	5 Participants n=157 Participants
Metastasis status Other metastasis	28 Participants n=527 Participants	4 Participants n=527 Participants	2 Participants n=1054 Participants	34 Participants n=157 Participants
Metastasis status No metastasis	4 Participants n=527 Participants	16 Participants n=527 Participants	3 Participants n=1054 Participants	23 Participants n=157 Participants
Metastasis status Not reported	0 Participants n=527 Participants	1 Participants n=527 Participants	0 Participants n=1054 Participants	1 Participants n=157 Participants

PRIMARY outcome

Timeframe: From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years.

Population: All patients who received at least two cycles of study treatment and had at least one evaluable post baseline tumor assessment.

Confirmed Objective Response Rate according to RECIST v1.1

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
ORR	2 Participants	15 Participants	8 Participants

SECONDARY outcome

Timeframe: Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.

Population: All patients who received at least two cycles of study treatment and had at least one evaluable post baseline tumor assessment, death, or discontinued treatment permanently.

PFS is defined as the time from first treatment with IMP to the first documented disease progression (based on disease evaluation done locally for all patients in accordance with RECIST v.1.1) or death from any cause. If a patient is not known to have progressed or died then they will be censored at the date of the last disease assessment. If a patient progresses after they have 2 or more missed disease assessment visits then they will be censored at the date of the last non missing disease assessment.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Progression Free Survival (PFS)	NA Months Interval 1.61 to Median not reached.	8.1 Months Interval 4.17 to 17.74	7.0 Months Interval 2.04 to 13.14

SECONDARY outcome

Population: All patients who received at least two cycles of study treatment and had at least one evaluable post baseline tumor assessment.

DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier). Date of progression and censoring will be handled in the same way as for PFS (evaluation done locally for all patients in accordance with RECIST v.1.1). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR. If a patient does not progress following a response, then their duration of response will use the PFS censoring time.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Duration of Response (DoR)	NA Months Interval 3.4 to Not reached	13.7 Months Interval 4.0 to Not reached	12.5 Months Interval 1.2 to Not reached

SECONDARY outcome

Population: All patients who received at least two cycles of study treatment and at least one evaluable post baseline tumor assessment.

CRR is defined as the number (%) of patients with a visit response of CR. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Complete Response Rate (CRR)	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Population: All patients who received at least two cycles of study treatment and at least one evaluable post baseline tumor assessment.

DCR is defined as the number (%) of patients with a visit response of PR or CR or SD. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Disease Control Rate (DCR)	2 Participants	25 Participants	12 Participants

SECONDARY outcome

Timeframe: From inform consent until death of any cause or withdrawal consent, whichever comes first, for up to 3 years.

Population: All patients who received at least two cycles of study treatment and at least one evaluable post baseline tumor assessment.

Overall survival is defined as the time from first dose of IMP until death from any cause. Patients not known to have died will be censored at the date last known to be alive. After disease progression, all patients are expected to be followed every 12 weeks to confirm their survival status. These follow-up visits/contacts continue until the last planned overall survival analysis.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=3 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=31 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=18 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Overall Survival (OS)	NA Months Interval 8.57 to Not reached	22.6 Months Interval 16.56 to Not reached	22.3 Months Interval 9.43 to Not reached

SECONDARY outcome

Population: All patients who received at least two cycles of study treatment and at least one evaluable post baseline tumor assessment.

In the subset of responding patients, TTR is defined as the time from first dose of IMP until the date of the first observed partial or complete response. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

Outcome measures

Outcome measures
Measure	Arm C (mUBC) n=2 Participants mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm A (NSCLC) n=15 Participants NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=8 Participants SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Time to Response (TTR)	2.07 Months Interval 1.74 to 2.09	2.04 Months Interval 1.97 to 2.09	2.10 Months Interval 2.0 to 4.07

Adverse Events

Arm A (NSCLC)

Serious events: 5 serious events

Other events: 33 other events

Deaths: 4 deaths

Arm B (SCCHN)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 1 deaths

Arm C (mUBC)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Mai-Britt Zocca

IO Biotech

Phone: +45 21947856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Arm A (NSCLC) n=37 participants at risk NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm B (SCCHN) n=21 participants at risk SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides	Arm C (mUBC) n=5 participants at risk mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W IO102-IO103 in combination with pembrolizumab: The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
Cardiac disorders Atrial fibrillation	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Cardiac disorders Cardiac failure	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Cardiac disorders Pericardial effusion	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Cardiac disorders Sinus bradycardia	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Eye disorders Eye discharge	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
General disorders and administration site conditions Death	5.4% 2/37 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
General disorders and administration site conditions Fatigue	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
General disorders and administration site conditions General physical health deterioration	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Hepatobiliary disorders Drug-induced liver injury	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Immune system disorders Drug hypersensitivity	2.7% 1/37 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Pneumonia	5.4% 2/37 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Infected skin ulcer	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Respiratory tract infection	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Sepsis	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Cellulitis	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Infections and infestations Escherichia bacteraemia	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Injury, poisoning and procedural complications Fall	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Metabolism and nutrition disorders Hyperglycaemia	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Nervous system disorders Cerebrovascular accident	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Nervous system disorders Seizure	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Nervous system disorders Syncope	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Nervous system disorders Ischaemic stroke	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Psychiatric disorders Mental status changes	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Reproductive system and breast disorders Prostatitis	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.4% 2/37 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.7% 1/37 • Number of events 2 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Productive cough	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	20.0% 1/5 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Vascular disorders Hypotension	2.7% 1/37 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/21 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.
Vascular disorders Jugular vein thrombosis	0.00% 0/37 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	4.8% 1/21 • Number of events 1 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.	0.00% 0/5 • From informed consent until death, withdrawal of consent or lost to follow up, for up to 3 years.