Trial Outcomes & Findings for A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer (NCT NCT02210559)

NCT ID: NCT02210559

Last Updated: 2023-03-02

Results Overview

An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
• Results posted on: 2023-03-02

Participant Flow

Participant milestones

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) Participants received gemcitabine at 1000 milligrams (mg)/ meters (m)\^2 plus nab-paclitaxel at 125 mg/m\^2 by intraveneous (IV) infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kilograms (kg) by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Overall Study STARTED	24	13
Overall Study Received at Least 1 Dose of Study Drug	24	13
Overall Study COMPLETED	18	7
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) Participants received gemcitabine at 1000 milligrams (mg)/ meters (m)\^2 plus nab-paclitaxel at 125 mg/m\^2 by intraveneous (IV) infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kilograms (kg) by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Overall Study Progressive Disease	3	2
Overall Study Adverse Event	2	2
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Other than specified	0	1

Baseline Characteristics

A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

Baseline characteristics by cohort

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.	Total n=37 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 7.75 • n=5 Participants	60.8 years STANDARD_DEVIATION 9.18 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.60 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	13 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)

Population: Safety population included all participants who had received any dose of study drug.

An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	24 Participants	12 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	9 Participants	6 Participants

PRIMARY outcome

Timeframe: 30 days following discharge after surgery (up to Day 198)

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants Who Had Surgical Complications Post-Resection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After completion of 24 weeks of treatment with study drug

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants Who Became Eligible for Surgery	17 Participants	2 Participants

SECONDARY outcome

Timeframe: After completion of 24 weeks of treatment with study drug

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

R0 resection was determined by pathological examination of the surgical specimen after resection.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants in Whom R0 Resection Was Achieved	4 Participants	1 Participants

SECONDARY outcome

Timeframe: After completion of 24 weeks of treatment with study drug

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants in Whom R0 or R1 Resection Was Achieved	8 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization up to Week 52

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	5 Participants	3 Participants

SECONDARY outcome

Timeframe: From randomization until death from any cause, assessed up to 4 years

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

Overall survival was defined as the time from randomization until death from any cause.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Median Overall Survival	19.38 months Interval 13.34 to 27.73	23.47 months Interval 13.27 to 46.46

SECONDARY outcome

Timeframe: From randomization until objective tumor progression or death, assessed up to 4 years

Population: ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.

Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 Participants Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 Participants Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Median Progression-Free Survival	14.11 months Interval 8.25 to 18.4	11.63 months Interval 3.88 to 20.4

Adverse Events

Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)

Serious events: 9 serious events

Other events: 24 other events

Deaths: 17 deaths

Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)

Serious events: 6 serious events

Other events: 12 other events

Deaths: 7 deaths

Serious adverse events

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 participants at risk Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 participants at risk Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Blood and lymphatic system disorders Lymphadenopthy	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Ascites	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Nausea	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Pancreatitis	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Vomiting	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Device occlusions	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Drug withdrawal syndrome	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Pyrexia	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Sepsis	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Cellulitis	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Urinary tract infection	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Injury, poisoning and procedural complications Craniocerebral injury	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.

Other adverse events

Measure	Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) n=24 participants at risk Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment.	Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) n=13 participants at risk Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment.
Blood and lymphatic system disorders Neutropenia	37.5% 9/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	30.8% 4/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Blood and lymphatic system disorders Anaemia	37.5% 9/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Cardiac disorders Sinus tachycardia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Cardiac disorders Tachycardia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Endocrine disorders Cushingoid	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Eye disorders Vision blurred	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Eye disorders Dry eye	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Nausea	70.8% 17/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	53.8% 7/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Diarrhoea	50.0% 12/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	53.8% 7/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Constipation	29.2% 7/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	46.2% 6/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Vomiting	41.7% 10/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Abdominal pain	25.0% 6/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Stomatitis	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Abdominal distension	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Dyspepsia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Pancreatic insufficiency	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Dry mouth	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Haemorrhoids	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Fatigue	75.0% 18/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	76.9% 10/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Oedema peripheral	58.3% 14/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	38.5% 5/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Pyrexia	29.2% 7/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Chills	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Gait disturbance	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Asthenia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Influenza like illness	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Non-cardiac chest pain	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
General disorders Mucosal inflammation	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Upper respiratory tract infection	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Cellulitis	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Urinary tract infection	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Pneumonia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Rash pustular	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Body tinea	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Infections and infestations Tooth infection	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Injury, poisoning and procedural complications Fall	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Neutrophil count decreased	29.2% 7/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Platelet count decreased	33.3% 8/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Alanine aminotransferase increased	25.0% 6/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Aspartate aminotransferase increased	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Blood alkaline phosphatase increased	16.7% 4/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Weight decreased	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Blood creatinine increased	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations White blood cell count decreased	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Investigations Troponin increased	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Metabolism and nutrition disorders Decreased appetite	50.0% 12/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	38.5% 5/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Metabolism and nutrition disorders Dehydration	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	16.7% 4/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 6/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Neuropathy peripheral	41.7% 10/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	23.1% 3/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	29.2% 7/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	30.8% 4/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Dizziness	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	23.1% 3/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Dysgeusia	25.0% 6/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Headache	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Hypoaesthesia	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Psychiatric disorders Insomnia	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	23.1% 3/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Psychiatric disorders Depression	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Psychiatric disorders Anxiety	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Renal and urinary disorders Nocturia	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 8/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 6/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 8/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	66.7% 16/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	53.8% 7/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash	29.2% 7/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	30.8% 4/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.8% 5/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	23.1% 3/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	16.7% 4/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 3/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Nail discolouration	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	4.2% 1/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	7.7% 1/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Vascular disorders Hypertension	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	15.4% 2/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Vascular disorders Deep vein thrombosis	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.
Vascular disorders Thrombophlebitis superficial	8.3% 2/24 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.	0.00% 0/13 • Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years. Safety population included all participants who had received any dose of study drug.

Additional Information

Clinical Trial Information Desk

FibroGen, Inc.

Phone: 415-978-1441

Email: FG3019-069Study@fibrogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
• Publication restrictions are in place

Restriction type: OTHER