Trial Outcomes & Findings for IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity (NCT NCT02609386)

Last Updated: 2024-01-30

Results Overview

EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen 1 IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamin is administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamin: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Overall Study STARTED	70	35
Overall Study COMPLETED	42	18
Overall Study NOT COMPLETED	28	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen 1 IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamin is administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamin: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Overall Study Withdrawal by Subject	6	1
Overall Study Lost to Follow-up	3	5
Overall Study Death	19	9
Overall Study Physician Decision	0	2

Baseline Characteristics

IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen 1 n=70 Participants IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days	Regimen 2 n=35 Participants Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Total n=105 Participants Total of all reporting groups
Age, Continuous	60.5 years n=99 Participants	61 years n=107 Participants	61 years n=206 Participants
Sex: Female, Male Female	22 Participants n=99 Participants	10 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	48 Participants n=99 Participants	25 Participants n=107 Participants	73 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=99 Participants	12 Participants n=107 Participants	40 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=99 Participants	22 Participants n=107 Participants	63 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	58 Participants n=99 Participants	25 Participants n=107 Participants	83 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Region of Enrollment Canada	2 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants
Region of Enrollment United States	43 participants n=99 Participants	24 participants n=107 Participants	67 participants n=206 Participants
Region of Enrollment Brazil	24 participants n=99 Participants	11 participants n=107 Participants	35 participants n=206 Participants
Region of Enrollment United Kingdom	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Primary Disease Stage Primary disease Stage I/II	26 Participants n=99 Participants	11 Participants n=107 Participants	37 Participants n=206 Participants
Primary Disease Stage Primary disease Stage III/IV	44 Participants n=99 Participants	24 Participants n=107 Participants	68 Participants n=206 Participants

PRIMARY outcome

Timeframe: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)

EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.

Outcome measures

Outcome measures
Measure	Regimen 1 n=70 Participants IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 Participants Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Event-free Survival (EFS)- Number of Participants With an Event	31 Participants	15 Participants

PRIMARY outcome

Timeframe: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)

EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Regimen 1 n=70 Participants IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 Participants Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
EFS- Time to Event	48.3 Months Interval 11.4 to The upper limit for median EFS was not estimated because it was longer than the latest censoring time, and therefore was not achieved	NA Months Interval 18.8 to Median EFS is not reported for the Regimen 2 population because it was not reached.The upper limit for median EFS was not estimated because it was longer than the latest censoring time, and therefore was not achieved.

SECONDARY outcome

Timeframe: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)

OS was defined as the time from randomization to death due to any cause.

Outcome measures

Outcome measures
Measure	Regimen 1 n=70 Participants IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 Participants Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Overall Survival (OS)- Number of Participants With an Event	19 Participants	11 Participants

SECONDARY outcome

Timeframe: From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months)

OS was defined as the time from randomization to death due to any cause. Data for partipants who were alive at the end of the study were censored at the last known alive date. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Regimen 1 n=70 Participants IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 Participants Regimen 1 but without IRX-2. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
OS- Time to Event	NA Months Median OS was not estimated because it was longer than the latest censoring time, and therefore was not achieved. In other words, there was an insufficient number of participants with events to calculate median OS, and the lower and upper limits of the 95% confidence interval	NA Months Interval 42.6 to Median OS (and upper 95% CI) was not estimated because it was longer than the latest censoring time, and therefore was not achieved. In other words, there was an insufficient number of participants with events to calculate median OS and the upper limit of the 95% confidence interval

Adverse Events

Regimen 1

Serious events: 29 serious events

Other events: 65 other events

Deaths: 19 deaths

Regimen 2

Serious events: 14 serious events

Other events: 31 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

Additional Information

VP of Quality

Eterna Therapeutics

Phone: 212-582-1199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor shall have the right to first publication. Following first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to Sponsor for review at least 60 days prior to the date of the proposed publication. Sixty days shall be extended to 120 days if Sponsor determines that the publication contains patentable matter.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Regimen 1 n=68 participants at risk IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 participants at risk Regimen 1 but without IRX-2 Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Cardiac disorders Atrial fibrillation	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Salivary gland fistula	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Vomiting	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Nausea	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Oral cavity fistula	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Oral pain	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Stomatitis	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Disease Progression	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Pyrexia	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Postoperative wound infection	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Abscess neck	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Pneumonia	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Cellulitis	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Wound infection	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Lung infection	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Osteomyelitis	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Postoperative abscess	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Sepsis	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Skin infection	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Soft tissue infection	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Tracheobronchitis	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Infections and infestations Upper respiratory tract infection	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Wound dehiscence	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Graft ischaemia	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Clavicle fracture	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Procedural haemorrhage	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Tongue injury	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Investigations Neutrophil count decreased	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Investigations White blood cell count increased	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Hypercalcaemia	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Malnutrition	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Musculoskeletal and connective tissue disorders Fistula	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.

Other adverse events
Measure	Regimen 1 n=68 participants at risk IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy. IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.	Regimen 2 n=35 participants at risk Regimen 1 but without IRX-2 Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV. Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days. Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days. Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days.
Blood and lymphatic system disorders Anaemia	16.2% 11/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	14.3% 5/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Cardiac disorders Atrial fibrillation	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Stomatitis	25.0% 17/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	25.7% 9/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Nausea	22.1% 15/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	17.1% 6/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Dry mouth	14.7% 10/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	17.1% 6/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Constipation	14.7% 10/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	11.4% 4/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Diarrhoea	17.6% 12/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Dysphagia	11.8% 8/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Oral pain	11.8% 8/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Vomiting	10.3% 7/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Glossodynia	7.4% 5/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Odynophagia	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Gastrointestinal disorders Oral cavity fistula	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Fatigue	14.7% 10/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	11.4% 4/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Injection site pain	7.4% 5/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Face oedema	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
General disorders Pyrexia	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Radiation skin injury	17.6% 12/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	11.4% 4/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Procedural pain	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Wound dehiscence	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Investigations Weight decreased	20.6% 14/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	17.1% 6/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Investigations Neutrophil count decreased	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Dehydration	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Hypokalaemia	4.4% 3/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	5.7% 2/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Decreased appetite	1.5% 1/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	0.00% 0/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Musculoskeletal and connective tissue disorders Neck pain	13.2% 9/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	11.4% 4/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Nervous system disorders Headache	8.8% 6/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	11.4% 4/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Nervous system disorders Dysgeusia	8.8% 6/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Psychiatric disorders Insomnia	2.9% 2/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Skin and subcutaneous tissue disorders Erythema	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	2.9% 1/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.
Vascular disorders Lymphoedema	5.9% 4/68 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.	8.6% 3/35 • AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months. \# of participants at risk for all-cause mortality (70) differs from # at risk for serious and other AEs in Regimen 1 (68) as the population assessed for all-cause mortality was the intent to treat (ITT) population, i.e., all randomized subjects whether or not they received any component of the regimen they were randomized to. # of participants at risk for AE/SAEs (68) corresponds to the safety population, i.e., all pts who received at least 1 dose of study regimen.