Trial Outcomes & Findings for TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer (NCT NCT03192462)

NCT ID: NCT03192462

Last Updated: 2025-10-29

Results Overview

To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

37 participants

Primary outcome timeframe

7 months

Results posted on

2025-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Overall Study STARTED	13	12	12
Overall Study COMPLETED	0	0	2
Overall Study NOT COMPLETED	13	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Overall Study Death	13	11	10
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=13 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 Participants Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Total n=37 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	51.5 years n=7 Participants	65 years n=5 Participants	63 years n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Participants who received at least one infusion of multiTAA-specific T cells.

To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.

Outcome measures

Outcome measures
Measure	Group A n=13 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 Participants Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Number of Patients With Treatment Related Serious Adverse Events	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who received at least one infusion of multiTAA-specific T cells.

To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease

Outcome measures

Outcome measures
Measure	Group A n=13 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 Participants Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells	9 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 5 years

Population: The analysis population includes all participants who received at least one infusion of multiTAA-specific T cells.

To evaluate the progression-free of patients after multiTAA-specific T cell infusions. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. PFS was defined as the time from the first infusion to the first occurrence of disease progression, relapse, or death from any cause. Patients without events were censored at the last follow-up date.

Outcome measures

Outcome measures
Measure	Group A n=13 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 Participants Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Progression Free Survival Using the Kaplan-Meier Method	6.4 months Interval 2.4 to 9.5	2.2 months Interval 1.2 to 2.5	7.5 months Interval 2.6 to 39.7

SECONDARY outcome

Timeframe: 5 years

Population: The analysis population includes all participants who received at least one infusion of multiTAA-specific T cells.

To evaluate the overall survival of patients after multiTAA-specific T cell infusions. Overall survival (OS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. OS was defined as the time from the first infusion to death from any cause. Patients without events were censored at the last follow-up date.

Outcome measures

Outcome measures
Measure	Group A n=13 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 Participants Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 Participants Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Overall Survival Using the Kaplan-Meier Method	14.1 months Interval 3.6 to 15.4	4.4 months Interval 1.5 to 16.7	12.6 months Interval 4.5 to 45.9

Adverse Events

Group A

Serious events: 4 serious events

Other events: 13 other events

Deaths: 13 deaths

Group B

Serious events: 6 serious events

Other events: 12 other events

Deaths: 11 deaths

Group C

Serious events: 3 serious events

Other events: 11 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Benjamin Musher

Baylor College of Medicine

Phone: (713)798-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Group A n=13 participants at risk Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 participants at risk Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 participants at risk Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Blood and lymphatic system disorders Anemia	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Cardiac disorders Sinus tachycardia	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Cholangitis	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Large bowel obstruction	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Ventral hernia	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Nausea	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Pancreatitis	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Chills	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Fever	23.1% 3/13 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify : Biliary Tract Obstruction	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify : Biliary obstruction	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Biliary tract infection	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Infections and infestations - Other, specify : E. coli bacteremia	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Infections and infestations - Other, specify : Infection	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Lung infection	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Sepsis	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Blood bilirubin increased	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Platelet count decreased	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Serum amylase increased	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify : Hemoptysis	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Vascular disorders Hypotension	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.

Other adverse events
Measure	Group A n=13 participants at risk Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group B n=12 participants at risk Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.	Group C n=12 participants at risk Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. multiTAA specific T cells: Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
Blood and lymphatic system disorders Anemia	53.8% 7/13 • Number of events 20 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 10 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	83.3% 10/12 • Number of events 33 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Cardiac disorders Sinus bradycardia	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Abdominal pain	38.5% 5/13 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	33.3% 4/12 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 7 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Bloating	15.4% 2/13 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Diarrhea	30.8% 4/13 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Dyspepsia	15.4% 2/13 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Flatulence	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Enteritis	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Indigestion	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify : Melena	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Hemorrhoids	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Nausea	38.5% 5/13 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Gastrointestinal disorders Vomiting	23.1% 3/13 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Chills	30.8% 4/13 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Edema face	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Edema limbs	7.7% 1/13 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Fatigue	46.2% 6/13 • Number of events 7 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	66.7% 8/12 • Number of events 13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	41.7% 5/12 • Number of events 5 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Fever	7.7% 1/13 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	33.3% 4/12 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Flu like symptoms	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions General disorders and administration site conditions - Other, specify : Body aches	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Malaise	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Non-cardiac chest pain	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
General disorders and administration site conditions Pain	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify : Biliary obstruction	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Sinusitis	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Infections and infestations Tooth infection	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Alanine aminotransferase increased	53.8% 7/13 • Number of events 19 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 5 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 8 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Alkaline phosphatase increased	46.2% 6/13 • Number of events 17 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 7 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	41.7% 5/12 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Aspartate aminotransferase increased	46.2% 6/13 • Number of events 16 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	33.3% 4/12 • Number of events 8 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	50.0% 6/12 • Number of events 11 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Blood bilirubin increased	23.1% 3/13 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	33.3% 4/12 • Number of events 6 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Creatinine increased	0.00% 0/13 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	8.3% 1/12 • Number of events 2 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	16.7% 2/12 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.
Investigations Lymphocyte count decreased	15.4% 2/13 • Number of events 3 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	0.00% 0/12 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.	25.0% 3/12 • Number of events 4 • All-Cause Mortality data was collected for 5 years and Serious and Other (Not Including Serious) Adverse Events were collected 8 weeks after the last dosing of the drug, up to 9 months. Adverse event data collection is still ongoing and will be updated upon study completion to include any additional adverse event data.